EXAMINATION GLOVES POWDER FREE IS A POWDER FREE LATEX DISPOSABLE DEVICE MADE OF NATURAL RUBBER LATEX INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINERS HAND ob eximali contrail contrainer time between batten and EXAMINER.

Device Description

Class I Patient Examination Gloves Latex (Powder free) 80L Y Y that meets all the requirements of ASTM D3578

AI/ML Overview

The device is a Latex Examination Glove (Powder free) manufactured by Brightway Gloves Pvt. Ltd., intended for medical purposes to prevent contamination between patients and examiners. The acceptance criteria and performance data are detailed below, comparing the device's characteristics against ASTM D3578 requirements.

1. Table of Acceptance Criteria and Reported Device Performance

Characteristic	Size	Acceptance Criteria (ASTM D3578 Requirement)	Reported Device Performance (Brightway Gloves Value)	Meets Criteria?
Length	EX-S	220 mm minimum	235-240 mm	Yes
	S	220 mm minimum	235-240 mm	Yes
	M	230 mm minimum	235-240 mm	Yes
	L	230 mm minimum	235-240 mm	Yes
Width	EX S	70 +/- 6 mm	70 mm	Yes
	S	80 +/- 6 mm	82 mm	Yes
	M	95 +/- 6 mm	93 mm	Yes
	L	111 +/- 6 mm	107 mm	Yes
Thickness	EX S	0.08 mm minimum	0.10 mm	Yes
	S	0.08 mm minimum	0.10 mm	Yes
	M	0.08 mm minimum	0.10 mm	Yes
	L	0.08 mm minimum	0.10 mm	Yes
Physical Properties (Before Ageing)
Tensile Strength		14 mpa min	20 - 22 mpa	Yes
Elongation at break %		700% min	750 - 800% (or 750-850% in performance data)	Yes
Physical Properties (After Ageing)
Tensile Strength		14 mpa min	18 - 20 mpa	Yes
Elongation at break %		500% min	700 - 800%	Yes
Performance Requirement
Freedom from Holes	Holes	AQL 4	AQL 1.5	Yes (lower AQL is better)
Dimension	Width, Length, Thickness	AQL 4	AQL 4	Yes
Physical Property	Tensile Strength, Elongation at Break	AQL 4	AQL 4	Yes
Powder Content		Not explicitly stated in ASTM D3578, but implied by "powder free"	1 +/- 1 mg per glove	N/A (meets "powder free" claim)
Protein Content		Not explicitly stated in ASTM D3578	80 +/- 20 ppm	N/A
Moisture Content		Not explicitly stated in ASTM D3578	0.8% max	N/A
Biocompatibility		Not explicitly stated in ASTM D3578	Biologically Compatible	N/A (meets general expectation)

2. Sample size used for the test set and the data provenance

The document states that the performance test data is for "Latex Examination Glove powder free manufactured by M/S Brightway Gloves Pvt.Ltd." However, the sample size used for these tests is not explicitly stated in the provided document. The data provenance is
retrospective by the manufacturer, Brightway Gloves Pvt. Ltd., located in Tamil Nadu, India.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The ground truth for the physical and performance properties of the gloves is established by the ASTM D3578 standard specifications. No human expert "ground truthing" is mentioned or implied for these types of measurements.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is a measurement of physical and performance characteristics against a standard, not a subjective assessment requiring adjudication among experts.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a Latex Examination Glove, not an AI or diagnostic medical device that would involve human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a Latex Examination Glove, not an AI or algorithmic device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth is based on the ASTM D3578 standard specifications for Latex Examination Gloves. These are established industry standards for the physical and performance characteristics of such gloves.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model, so there is no concept of a "training set."

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this type of device.

Summary

{0}------------------------------------------------

510K SUMMARY as required by: 807.92( c ) 1.0.

2.0 APPLICANT

92(c)
K014279

MAR 2 0 2002

PAGE NO- 56

NAME

ADDRESS

M/s. BRIGHTWAY GLOVES PVT.LTD.

PIONEER MANIKANDAN BUILDINGS. VADASERY, NAGERCOIL, TAMIL NADU,

INDID-629001.

91-4652- 276291 / 276046 . PH.NO.

FAX NO 91-4652- 274271 .

CONTACT PERSON MR. N.PARAMASIVAN MANAGING DIRECTOR. 3. DEVICE TRADE NAME : NIL COMMON NAME : Latex Examination Glove (Powder free)

Legally marketed device to which the company claiming equivalence: Class I Patient Examination Gloves Latex (Powder free) 80L Y Y that meets all the requirements of ASTM D3578.
DESCRIPTION OF THE DEVICE:

Class I Patient Examination Gloves Latex (Powder free) 80L Y Y that meets all the requirements of ASTM D3578

Intended use of the Device:

Latex Examination Glove (Powder free) is a Powder free devices made of Natural Latex intended for medical purpose that is worn on the examiners hand or finger to prevent contamination between patient and examiner.

Image /page/0/Picture/15 description: The image shows a circular stamp with the words "BRIGHTWAY GLOVES PVT. LTD." written around the outer edge of the circle. Inside the circle, the word "NAGERCOIL" is written in bold letters. There is a star symbol at the bottom of the stamp.

{1}------------------------------------------------

PAGE NO-57

7.0 TECHNOLOGICAL CHARACTERSTICS OF THE DEVICE COMAPARED TO PREDICATE DEVICE.

Measured Parameters of LatexExamination gloves (Powder free)manufactured by Brightway GlovesPvt.Ltd.,			ASTM D3578Requirement forLatex Examinationglove (Powder free)
Characteristics	SIZE	Value
1. Length	EX-S	235-240 mm	220 mm minimum
	S	235-240 mm	220 mm minimum
	M	235-240 mm	230 mm minimum
	L	235-240 mm	230mm minimum
2. Width	EX S	70MM	70 +/- 6 mm
	S	82 mm	80 +/- 6 mm
	M	93 mm	95 +/- 6 mm
	L	107 mm	111+/- 6mm
3. Thickness	EX S	0.10mm	0.08 mm minimum
	S	0.10mm	0.08 mm minimum
	M	0.10mm	0.08 mm minimum
	L	0.10mm	0.08 mm minimum

PHYSICAL PROPERTIES

	BEFORE AGEING		AFTER AGEING
CHARACTERISTICS	BrightwayGloves Value	ASTD 3578REQUIREMENT	BrightwayGlovesValue	ASTD 3578Requirement
Tensile Strength	20 - 22 mpa	14 mpa min	18 - 20 mpa	14 mpa min
Elongation at break %	750 - 800%	700% min	700-800%	500% min

Image /page/1/Picture/5 description: The image is a circular stamp with the words "BRIGHTWAY GLOVES PVT. LTD." written around the border of the circle. In the center of the circle, the word "NAGERCOIL" is written in bold letters. A five-pointed star is located at the bottom of the circle.

{2}------------------------------------------------

PAGE NO-58

PERFORMANCE REQUIREMENT

Characteristics	Related defects	Level followedBy		AQLfollowed byBGPL	AQL Value asper ASTMD3578.
		*BGPL	As perASTMD3578
Freedom fromHoles	Holes	S4	S4	1.5	4
Dimension	Width , LengthThickness.	S2	S2	4	4
PhysicalProperty	TensileStrength,Elongation atBreak	S2	S2	4	4

POWDER CONTENT

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---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------.LANSAN O----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------.A Box 4 Total Concess and Career Schools and Childred	-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------1 1984 1991-1991 1999 1999 1999 1999 1999 1999 1999 19991. COR IN AND CONSULERS OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTCompany of Children Company of Children Company of Children Company of Children-----I a more in propos consistentialized by a

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------.Company of Children and College of College of Contract Concessfully children and Children Contraction of Children Contraction Concession Concession Concession Concession Conc.

..A--------------------BREAD CONSULT OF COLLECTION COLLEGION COLLECTION COLLEGION COLLECTION COLLECTION COLLECTION COLLECTION COLLECTION COLLEGION COLLECTION COLLECTION COLLECTION COLLECTION COLLEC------------------------------------------------------------------------------------------------------------------------------------------------------------------------------.-----------------A STATUTE A CONSULT OFLEGILE IIand and the comments of the first of the first and the comments of the comments of the comments of the comments of the comments of the comments of the form of the former of tCALLER BELL CREASE CONSULER COLLECTION COCONTRACT COLLEGICAL COLLEGION COLLEGE COLLEGIONAL

---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------.LANSAN O----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------.A Box 4 Total Concess and Career Schools and Childred

-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------1 1984 1991-1991 1999 1999 1999 1999 1999 1999 1999 19991. COR IN AND CONSULERS OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTCompany of Children Company of Children Company of Children Company of Children-----I a more in propos consistentialized by a

PROTEIN CONTENT:

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---------19 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11-------------------------------------------STATUTION CONSULTATION CONSULTATION CONSULTACALLARYAND ANNUAL I ANNUALIZED AND LIGHT LE LEA LEA LEA LEA LEA LEA LEA LEA LEA LEA LEA LEA LEA LEA LEA LEA LEA LEA LEA LEA LEA LEA LEA LEA LEA LEA LEA LEA LEA LEA LEA LEA LEA LEA L----------------------------------------------------------------------------------------------------------------------------MAR R LE LEBERTE LE REGIONAL14 11 11 11 10 10 10 100 10 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 10Comments of Children College of ChildrenCONTRACT AND REALER COLOR COLUMN CALLERYCarrely Station1.	Comment------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------. IN ALBURANT AND ANNALARIA ALL BULLER AND AND AND ALL PRODUCT AND------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Caller Manager------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Comments of the Comments of Children------------------------------------------------------------------------------------------------------------------------------------------------------------------------------The first and the county of the county of the county of the county of the county of

LEE REE E E RESER EN RESELLENTESThe Property of Children and Children and Children and Children Comments of Children1. 11. 11. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1And Income of Children Commend Commend College of Children Comments of Children Comments of Children Comments of Children Comments of Children of Children of Children of ChilA SHOR AND A.------------------------------------------------------------------------------------------------------------------------------------------------------------------------------STATUTE FOR THE FORM FOR COLLECTION OF COLLECTION OF COLLECTION OF COLLECTION OF COLLECTION OF COLLECTION OF COLLECTION OF COLLECTION OF COLLECTION OF COLLECTION OF COLLECTIO.--------------www.asharakamada.com/debable/ship/article/station/articles/articles/articles/articles/articles/articles/articles/articles/articles/articles/articles/articles/articles/article.A manager of the contracts of the first of the first for------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

---------19 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11-------------------------------------------STATUTION CONSULTATION CONSULTATION CONSULTACALLARYAND ANNUAL I ANNUALIZED AND LIGHT LE LEA LEA LEA LEA LEA LEA LEA LEA LEA LEA LEA LEA LEA LEA LEA LEA LEA LEA LEA LEA LEA LEA LEA LEA LEA LEA LEA LEA LEA LEA LEA LEA LEA LEA L----------------------------------------------------------------------------------------------------------------------------MAR R LE LEBERTE LE REGIONAL14 11 11 11 10 10 10 100 10 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 10Comments of Children College of ChildrenCONTRACT AND REALER COLOR COLUMN CALLERYCarrely Station1.

Comment------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------. IN ALBURANT AND ANNALARIA ALL BULLER AND AND AND ALL PRODUCT AND------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Caller Manager------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Comments of the Comments of Children------------------------------------------------------------------------------------------------------------------------------------------------------------------------------The first and the county of the county of the county of the county of the county of

MOISTURE CONTENT:

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Canada****------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------The first of the country of the county of the county of the county of the first of the first of the first andCarles Comments of Concession Company Construction Comparison Comparis Comparis Comparis Comparis Comparis Comparis Comparis Comparis Comparis Comparis Comparis Comparis CompCOLLECTION WANTED CALL ALL ALL ALL ALL ALL ALL AND A BREATH AND A BREATH ANDCommon an calculation of the pro-STATUTE OF STATUTE AND THE LEASE OF LEASE OF CHEARTHAn anticle of the proposedThe summer of the control of the first of the first of the first of the first of the first and the first and the first and the first and the first and the first and the first------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	11 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 1------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------To A LI MIND & MINNING A LE CONSULERS AND CONSULTION CON-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Comprehensive program and proposition of the control control control control and concerner and concession of the control and concession of the contribution of the contributio

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------.------------------------------------------------------------------------------------------------------------The first and the program and the state of the same of the same of the same of the same of------------------------------------------------------------------------------------------------------------------------------------------------------------------------------The The Research and Income and the commended of------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

"Hill Address and Children and the summer on the second of the second of the commended to the commended to the commended to theI. IN NOW, CANNONIA FOR COLLEGE A COUNTY CANNOR PATIENT PATIENT PATIENT PATIENT PLANES OF CLAIM OFAcres of the commended inThe program of the state of the state of the state of the state of the states of the states of---------------------------------------annual program and proposalism and the production of the continues and the continues andand the comments of the consisted on the comments of the comments of the comments of the comments ofand and the state and problemAn and Change of Children Company ofand and the do station of the production of the de-.

Canada****------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------The first of the country of the county of the county of the county of the first of the first of the first andCarles Comments of Concession Company Construction Comparison Comparis Comparis Comparis Comparis Comparis Comparis Comparis Comparis Comparis Comparis Comparis Comparis CompCOLLECTION WANTED CALL ALL ALL ALL ALL ALL ALL AND A BREATH AND A BREATH ANDCommon an calculation of the pro-STATUTE OF STATUTE AND THE LEASE OF LEASE OF CHEARTHAn anticle of the proposedThe summer of the control of the first of the first of the first of the first of the first and the first and the first and the first and the first and the first and the first------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

11 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 1------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------To A LI MIND & MINNING A LE CONSULERS AND CONSULTION CON-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Comprehensive program and proposition of the control control control control and concerner and concession of the control and concession of the contribution of the contributio

BIOCOMPATABILITY: 1 :

STATIS OF ARTS CHARACT LAND A FOR FOR------------------------Barry of consideration of the different of the childrenFREE EN FREE FREE FREE FOR FOR FOR FOR FOR-----------A B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B LCARD COLORIAL I CORRESS OF CHILIFERSLAND AN AND COLLECTION COLLEGION COLLEGION-------	--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------IN AND LE FREEDERS COLLECTIONThe first of the county of the county of the county of the county of the county of------------------------------------------------------------------------------------------------------------------------------------------------------------------------------· Children Children Children a provention a provention of a provention of a proventually of140000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000Callery of Children Controllers.--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------.Comments of the comments of the program and the program and the comments of the comments of the comments of the comments of the comments of the first of the first of the firs------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
1Company College of the Cases of Children and Children and Charles and Charles forLA MI LE LEAR REAL PRODUCTION COLLEGION COLLEGION COLLEGION COLLEGION CONTRACTOR COLLEGION CONTRACTOR COLLEGION OFSHEET MILE A CHILLE WIER & LE BE LEWING------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Comments of the contraction of the comments of the comments of the first of the first of the first ofA MILL AND LEASE LEASE LEASE LEASE LEASE LEASE------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Section of a consideration do a	CHARAC AND THE CONSULT CONSULTION CONSULTION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGIONStatus of Children CollegeIn more company andSTATUTE AND THE PERSONAL------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Company of the control control control control control control control control of the consisted on the consisted on the consisted on the control ofANNUAL PRODUCT OF CHARACT OF CHARACT OF CHARACT AND A CARDER A CARDER A CARRET A CARRETT A CARRET A CARAL A CARAL A CARAL A CARAL A CARAL A CARAL A CARAL A CARAL A CARA A.STANDARD STATUTE LE LEASE MENT.The state of the count of the first and and and and and and the first and any and

STATIS OF ARTS CHARACT LAND A FOR FOR------------------------Barry of consideration of the different of the childrenFREE EN FREE FREE FREE FOR FOR FOR FOR FOR-----------A B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B LCARD COLORIAL I CORRESS OF CHILIFERSLAND AN AND COLLECTION COLLEGION COLLEGION-------

--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------IN AND LE FREEDERS COLLECTIONThe first of the county of the county of the county of the county of the county of------------------------------------------------------------------------------------------------------------------------------------------------------------------------------· Children Children Children a provention a provention of a provention of a proventually of140000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000Callery of Children Controllers.--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------.Comments of the comments of the program and the program and the comments of the comments of the comments of the comments of the comments of the first of the first of the firs------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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CHARAC AND THE CONSULT CONSULTION CONSULTION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGIONStatus of Children CollegeIn more company andSTATUTE AND THE PERSONAL------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Company of the control control control control control control control control of the consisted on the consisted on the consisted on the control ofANNUAL PRODUCT OF CHARACT OF CHARACT OF CHARACT AND A CARDER A CARDER A CARRET A CARRETT A CARRET A CARAL A CARAL A CARAL A CARAL A CARAL A CARAL A CARAL A CARAL A CARA A.STANDARD STATUTE LE LEASE MENT.The state of the count of the first and and and and and and the first and any and

*BGPL-Brightway Gloves Pvt.ltd

Image /page/2/Picture/12 description: The image shows a circular stamp with the words "IGHTWAY GLOVES PVT. LTD" around the edge. In the center of the stamp, the word "HAGERCOIL" is written in a smaller font. The stamp appears to be slightly faded or worn, giving it a vintage or official look.

{3}------------------------------------------------

8.0 Performance Data:

The performance test data of the Latex Examination Glove powder free manufactured by M/S Brightway Gloves Pvt.Lltd. is given below.

Measured Parameters of LatexExamination gloves (Powder free)manufactured by Brightway GlovesPvt.Ltd.,
Characteristics	SIZE	Value
1. Length	EX-S	235-240 mm
	S	235-240 mm
	M	235-240 mm
	L	235-240 mm
2. Width	EX S	70MM
	S	82 mm
	M	93 mm
	L	107 mm
3. Thickness	EX S	0.10mm
	S	0.10mm
	M	0.10mm
	L	0.10mm

PHYSICAL PROPERTIES

CHARACTERISTICS	Before Ageing	AfterAgeing
Tensile Strength	20-22 mpa	18-20 mpa
Elongation at break %	750-850%	700-800%

INSPECTION LEVEL OF AQL:

Characteristics	Related defects	Level	AQL
Freedom fromHoles	Holes	S4	1.5
Dimension	Width , LengthThickness.	S2	4
PhysicalProperty	TensileStrength,Elongation atBreak	S2	4

GLOVE 2 1 NAGERCALI

{4}------------------------------------------------

POWDER CONTENT: 1 +/- 1 mg per glove

PROTEIN CONTENT: 80 +/- 20 ppm

MOISTURE CONTENT: .0.8% max

BIOCO MPATABILITY: Biologically Compatible.

NA 9. Clinical Data 0

7. CONCLUSION OF PERFORMANCE TEST DATA:

The Latex Examination gloves Powder free manufactured by M/S Brightway Gloves Pvt.Ltd.

Meet or exceed the ASTM D3578 a
Meet FDA Pin hole Requirement. -
Meet labelling claim as shown by the data in 6 -

8. ANY OTHER INFORMATION:

Any other information required by FDA regarding product safety and effectiveness will be provided on request.

Image /page/4/Picture/13 description: The image shows a circular stamp with the text "LIGHTWAY GLOVES PVT. LTD." around the outer edge of the circle. In the center of the circle, the text "NAGERCOIL" is printed in a bold, sans-serif font. The stamp appears to be slightly smudged, giving it a worn or used appearance.

{5}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 0 2002

Mr. N. Paramasivan Managing Director Brightway Gloves PVT. LTD. Pioneer Manikandan Building Vadasery, Nagar Coil, Tamil Nadu, INDIA

Re: K014279

Trade/Device Name: Latex Examination Gloves (Powder Free) Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: December 27, 2001 Received: December 27, 2001

Dear Mr. Paramasivan:

We have reviewed your Section 510(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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

{6}------------------------------------------------

Page 2 – Mr. Paramasivan

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 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

{7}------------------------------------------------

Page

510(k) NUMBER (IF KNOWN): K014279 LATEX EXAMINATION GLOVES (POWDER FREE) DEVICE NAME : INDICATIONS FOR USE:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter-Use (Optional Format 1-2-96

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Dev 510(k) Number _

Regulation Number and Section

§ 880.6250 Non-powdered patient examination glove.

(a)
Identification. A non-powdered 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. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.