Nitrile Examination Gloves Specifications

Specification
Description Length Thickness/mm Packing
Size Weight/g Width /mm
/mm
S 3.5±0.3 85±5
Cuff:0.06±0.02 100 pcs/box
Nitrile Glove M 3.8±0.3 240mm 95±5
Palm:0.07±0.02 10 boxes/carton
Powder free L 4.2±0.3 ±10mm 105±5
Finger:0.125±0.02
XL 4.6±0.3 115±5

Standard: ASTM D6319

Class 1 FDA 510K: K123488
Freedom from Holes: AQL 1.5
ISO13485: 2016 Available
EN455: Part 1, 2, 3 Test Available
EN420: Available
END374: Part 2, 4 Test Available

Product Name: Disposable Nitrile/Vinyl Exam Gloves

Size: See package
Manufacturer Name: Puyang Linshi Medical Supplies Co., Ltd., Industrial Park, Puyang County, China
Distributor Name: Allied Medical Products, 1800 US Highway 51 N, Woodruff, WI 54568
Product Feature: Non-toxic, no microbial pollution, no impurities, no leakage, high temperature resistance.
Main Component: Nitrile Rubber, Vinyl (PVC - Poly Vinyl Chloride-and-Phthalates DINP)
Usage: Single Use Only, Ambidextrous, Non-Sterile
Mfg Date: See package
Shelf Life: See package
Storage: Store in cool dry place. Do not store above 104F, in humid areas or in direct sunlight.
21 DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

a4 Food and Drug Administration

10903 New Hampshire Avenue
Documnent Control Center - W066-G609-
Silver Spring, MD 20993-0002

February 8, 2013

Puyang Linshi Health Company, Limited

C/O Ms. Laura Weng
Vice President, Operations
Linshi Chemical America Company, Limited
17800 Castleton Street, Suite 328
CITY OF INDUSTRY CA 91748

Re: K123488
Trade/Device Name: Powder-Free Nitrile Gloves, Blue Color
Regulation Number: 21 CFR 880.6250
Regulation Name: Patient Examination Glove
Regulatory Class: LZA
Product Code: I
Dated: January 23, 2013
Received: January 24, 2013

Dear Ms. Weng:

We have reviewed your Section 5 10(k) premarket notification of intent to market the device
referenced above and have determined the device is substantially equivalent (for the indications
for use stated in the enclosure) to legally marketed predicate devices marketed in interstate
commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to
devices that have been reclassified in accordance with the provisions of the Federal Food, Drug,
and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA).
You may, therefore, market the device, subject to the general controls provisions of the Act. The
general controls provisions of the Act include requirements for annual registration, listing of
devices, good manufacturing practice, labeling, and prohibitions against misbranding and
adulteration. Please note: CDRH does not evaluate information related to contract liability
warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class 11 (Special Controls) or class III (PMA), it
may be subject to additional controls. Existing major regulations affecting your device can be
found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may
publish further announcements concerning your device in the Federal Register.
Page 2 - Ms. Weng

Please be advised that FDA's issuance of a substantial equivalence determination does not mean
that FDA has made a determination that your device complies with other requirements of the Act
or any Federal statutes and regulations administered by other Federal agencies. You must comply
with all the Act's requirements, including, but not limited to: registration and listing (21 CFR
Part 807); labeling (21 CFR Part 80 1); medical device reporting (reporting of medical device-
related adverse events) (21 CER 803); good manufacturing practice requirements as set forth in
the quality systems (QS) regulation (21 CER Part 820); and if applicable, the electronic product
radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
go to httv://www.fda.gov/AboutFDA/CentersOffices/CDRHl/CDRHOffices/ucm 15 809.htm for
the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please
note the regulation entitled, "Misbranding by reference to premarket notification" (2ICFR Part
807.97). For questions regarding the reporting of adverse events under the MDR regulation (21
CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safetv/ReportaProblem/defaulthtm for the CDRI-'s Office
of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the
Division of Small Manufacturers, International and Consumer Assistance at its toll-free number
(800) 638-2041 or (301) 796-7100 or at its Internet address
http://Nvww.fda.uiov/MedicalDevices/ResourcesforYou/Industrv/default.htm.

Sincerely yours,

Anthony D. Watson, B.S., M.S., M.B.A.

Director
Division of Anesthesiology, General Hospital,
Respiratory, Infection Control and
Dental Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure
4.0 Indications for Use Statement
Device Name:
Powder-Free Nitrile Examination Gloves, Blue Color

Indications for Use:

A powder-free patient examination glove is a disposable device intended for medical
purposes that is worn on the examinees hand or finger to prevent contamination between
patient and examiner.

Prescription Use_ __ AND/OR Over-The-Counter Use X

(21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE

IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabeth F.C'Iaverie
2013.02.0711/'&55:51 -05100'1
(Division o804tM~lIfY General Hospital
Infecion Control. Dental Devics

6100k) Numfbec K v 3q-g

 FEB 08 2fl13
5.0 510(k) Summary (23 £
Submitter /Puyang Linshi Medical Supplies Co., Ltd.Industrial Park, Puyang County
Manufacturer I(East of Changsheng Road)
510(k) Owner: Puyang City, 457100 Henan Province, China Telephone: 0086-393-333-
1066
Fax: 0086-393-333-9566
Manufacturer Contact Person
Mr. Frank Yanhai Lv
Assistant of the President
1vyanhai~linshichem.com
Application Ms. Laura Weng
Correspondent: Vice President, Operations
lauraw@usalinshi.com
Linshi Chemical America Co., Ltd.
17800 Castleton St. Suite# 328
City of Industry, CA 91748
Telephone: 626-581-3030
Fax: 626-581-3035
Date Prepared: January 23, 2013
Trade Name: Linshi Health Nitrile Disposable Exam Gloves, Powder-Free
Common Exam Gloves
Name:
Classification: Class I
Patient Examination Glove
21 CER 880.6250
Product Code: LZA
Predicate The subject device is equivalent to the following device:
Device(s): K121947
ETS Blue Powder Free Nitrile Patient Examination Glove
Device Non-sterile, single-use, powder-free nitrile patient examination gloves
Description: (blue color), that meet requirements of ASTM D6139-10.
Intended Use: A powder-free patient examination glove is a disposable device intended
for medical purposes that is worn on the examiner's hand or finger to
prevent contamination between patient and examiner.
1K\P3t4

Summary of The powder-free blue nitrile examination glove is substantially equivalent

Technological to the predicate device with regard to physical characteristics, design,
Characteristics product features, and intended use.

ETh bILW 1 Powder Fred. Linshi Health Nitrile

Nitrile Exam Gloves
- - Disposable Exam Gloves,
FeatureK121947 -- Powder-Fre-e
Predicate Device.
- Subject Device
ClsiiainClass I Same
Clasifiction Patient Examination Glove
Product Code LZA Same
Regulation 21 CFR 880.6250 Same
gove s a
The xamnatin A powder-free patient
The examination glove is a
disposable device intended eainpation govie iseda
Indications for for medical purposes that is frdis uposaldeiesntended
Use worn on the examinees hand fomia purose tatis
or ofiger
prvent hand or finger to prevent
contamination between cotmninbewn
patint
nd eamier, patient and examiner.
Non-sterile, powder free,
Description examination gloves made of Same
nitrile and colored blue.
Packaging Non-sterile gloves are Same
provided in dispenser boxes.
Sterilization Non-Sterile Same
Single Use Yes Same
Ambidextrous Yes Same
Dimensions Meets ASTM D631 9-10 Same
Tensile Strength Meets ASTM D6319-10 Same
Ultimate Meets ASTM D6319-1 0 Same
Elongation
Freedom from .Meets ASTM 05151-06 and Same
Pinholes ASTM D6319-10 ___________

Residual Powder Meets ASTM D6124-06 Same

Passes Primary Skin Irritation Sm
BiocompatibilityinRbtsSm
Passes Cloedac
ISensitization in Gie isSm

Conclusion: Puyang Linshi Health Co., Ltd. considers the Linshi Health Nitrile
Disposable Exam Gloves, Powder-Free to be equivalent to the predicate
device listed above. This conclusion is based upon the devices'
similarities in principles of operation, technology, materials and
indications for use.