Powder free Surgeon's glove is a sterile powder free medical device intended to be worn by operating room personnel to protect a surgical wound from contamination.

Device Description

Class I Powder free Surgical Glove 79KGO that meets all 'the requirements of ASTM D3577.

AI/ML Overview

This document is a 510(k) summary for a Sterile Latex Surgeon's Glove (Powder Free). It focuses on demonstrating substantial equivalence to a predicate device by meeting ASTM D3577 and FDA requirements.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Characteristic	Acceptance Criteria (ASTM D3577 / FDA Requirement)	Reported Device Performance	Meets Criteria?
Dimensions
Length (5 ½ - 9)	245 mm minimum (for 5 ½), 265 mm minimum (for 6-9)	270-272 mm (all sizes)	Yes
Width (5 ½)	70 +/- 6 mm	68 mm	Yes
Width (6)	76 +/- 6 mm	73 mm	Yes
Width (6 ½)	83 +/- 6 mm	79 mm	Yes
Width (7)	99 +/- 6 mm	87 mm	Yes
Width (7 ½)	95 +/- 6 mm	92 mm	Yes
Width (8)	105 +/- 6 mm	103 mm	Yes
Width (8 ½)	108 +/- 6 mm	106 mm	Yes
Width (9)	114 +/- 6 mm	112 mm	Yes
Thickness	0.1 mm minimum (cuff, palm, fingertip)	0.12, 0.16, 0.19 mm (cuff, palm, fingertip)	Yes
Physical Properties (Before Ageing)
Tensile Strength	24 mpa	27 mpa	Yes
Elongation at break %	750%	850%	Yes
Modulus at 500% elongation	5.5 mpa (max)	3 mpa	Yes
Physical Properties (After Ageing)
Tensile Strength	18 mpa min	20 mpa	Yes
Elongation at break %	560% min	750%	Yes
Performance Requirements
Sterility	As per USP*	As per IP*	Yes (equivalent standard)
Freedom from Holes	1.5 AQL (S4)	1.5 AQL (S4)	Yes
Dimension	4 AQL (S2)	4 AQL (S2)	Yes
Physical Property	4 AQL (S2)	4 AQL (S2)	Yes
Additional Properties
Powder Content	2 mg/glove max	Nil Powder (1 +/- 1 mg/glove)	Yes
Protein Content	200 ppm max	80 +/- 20 ppm	Yes
Moisture Content	N/A (implied by "value fixed", "0.8% max")	0.8% max	Yes
Biocompatibility	Biologically Compatible	Biologically Compatible	Yes

Note: IP (Indian Pharmacopeia) is considered equivalent to USP (United States Pharmacopeia) for sterility in this context.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample sizes used for each individual test (e.g., how many gloves were tested for length, width, tensile strength, etc.). However, it refers to general AQL (Acceptance Quality Limit) levels (S2 and S4) for performance requirements like freedom from holes, dimensions, and physical properties. These AQL levels imply a sampling plan, but the exact number of units sampled is not provided.

The data provenance is for gloves manufactured by Brightway Gloves Pvt. Ltd. in Tamil Nadu, India. This is retrospective data, as it describes the performance of already manufactured gloves.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This document does not involve a test set requiring expert ground truth establishment in the traditional sense (e.g., image interpretation). Instead, the "ground truth" for compliance testing is established by recognized standards: ASTM D3577 (Standard Specification for Rubber Surgical Gloves) and FDA requirements/USP/IP standards. Therefore, no specific number of human experts for ground truth is applicable here. The experts involved are those who developed and maintain these national and international standards.

4. Adjudication Method for the Test Set

Not applicable. The evaluation is based on direct measurement and comparison against defined standard specifications, not on subjective expert consensus.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is a performance specification and substantial equivalence study for a medical device (surgical gloves), not an AI algorithm requiring MRMC studies.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This study is about the physical and chemical properties of a medical device, not an algorithm.

7. Type of Ground Truth Used

The ground truth used is established industry and regulatory standards:

ASTM D3577 requirements for latex surgeon's gloves.
FDA requirements for attributes like pinholes and protein content.
USP (United States Pharmacopeia) or IP (Indian Pharmacopeia) for sterility.

8. Sample Size for the Training Set

Not applicable. This device is manufactured using a process, and its performance is evaluated against specifications, not "trained" in the way an AI model is trained.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for this type of device. The manufacturing process is designed to meet the established standards and is subject to quality control to ensure consistency.

Summary

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MAY 2 2 2002

PAGE NO : 75

510K SUMMARY as required by: 807.92(c)

K014283

1.0 APPLICANT

BRIGHTWAY GLOVES PVT.LTD NAME : ADDRESS PIONEER MANIKANDAN BUILDINGS, VADASERY NAGAR COIL, TAMIL NADU, INDIA - 629001. PH.NO. 91-4652-276291, 276046. . FAX NO 91-4652-274271 ﻪ

CONTACT PERSON : N. PARAMASIVAN : MANAGING DIRECTOR

DEVICE TRADE NAME : NIL

COMMON NAME : Surgeon's Glove

: Powder free Surgeon's Glove Classification Name

1. Legally marketed device to which the company claiming equivalence: Class I Surgeon's Glove ( Powder free) 79KGOthat meets all the requirements of ASTM D3577.

5. DESCRIPTION OF THE DEVICE :

Class I Powder free Surgical Glove 79KGO that meets all 'the requirements of ASTM D3577.

6.0 Intended use of the Device:

Powder free Surgeon's glove is a Powder free Medical Device intended tobe worn by Operating room personnel to protect a surgical wound from contamination.

Image /page/0/Picture/15 description: The image shows a circular stamp with the words "BRIGHTWAY GLOVES PVT. LTD." around the outer edge. Inside the circle, the word "NAGERCOIL" is printed in bold, block letters. A five-pointed star is located at the bottom of the stamp.

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PAGE NO : 76

7.0 Technological characteristics of the device compared to predicate device.

Measured Parameters of LatexSurgeon's gloves (Powder free)manufactured by Brightway GlovesPvt.Ltd			ASTM D3577Requirement forLatex Surgeon's glove(Powder free)
Characteristics	SIZE	Value
1. Length	5 ½	270-272 mm	245 mm minimum
	6	270-272 mm	265 mm minimum
	6 ½	270-272 mm	265 mm minimum
	7	270-272 mm	265mm minimum
	7 ½	270-272 mm	265 mm minimum
	8	270-272 mm	265 mm minimum
	8 ½	270-272 mm	265 mm minimum
	9	270-272 mm	265 mm minimum
2. Width	5 ½	68 mm	70 +/- 6 mm
	6	73mm	76 +/- 6mm
	6 ½	79mm	83 +/- 6 mm
	7	87mm	99 +/- 6 mm
	7 ½	92mm	95 +/- 6 mm
	8	103mm	105+/- 6 mm
	8 ½	106mm	108 +/- 6 mm
	9	112mm	114+/- 6 mm

1. Thickness at cuff , Palm and finger tip of all the size is 0 .12, 0 .16 and 0.19mm.
  ASTM D3577 requirement for thickness at cuff, palm and finger tip is 0.1 mm minimum.

PHYSICAL PROPERTIES:

	BEFORE AGEING		AFTER AGEING
Characteristics	BGPL Value	ASTMD3577Requirement	BGPL Value	ASTMD3577Requirement
Tensile Strength	27 mpa	24 mpa	20 mpa	18 mpa min
Elongation at break %	850%	750%	750%	560% min
Modulus at 500 %elongation.	3 mpa	5.5 mpa(max)	-	-

Image /page/1/Picture/7 description: The image shows a circular stamp with the words "BRIGHTWAY GLOVES PVT. LTD." around the outer edge of the circle. In the center of the circle, the word "NAGERCOIL" is printed in bold, block letters. There is a small design at the bottom of the circle.

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PAGE NO : 77

PERFORMANCE REQUIREMENT:
Characteristics	Related defects	Level followed By	Level As per ASTM D 3577	AQL followed	AQL as per ASTM D3577.
		BGPL
Sterility	Fails sterility	As per IP*	As per USP*.	NA	NA
Freedom from Holes	Holes	S4	S4	1.5	1.5
Dimension	Width ,LengthThickness.	S2	S2	4	4
Physical Property	Tensile strength,Elongation at break before and after ageing.	S2	S2	4	4

IP — INDIAN PHARMACOPEA

POWDER CONTENT

BGPL VALUE	ASTM REQUIREMENT
Nil Powder	2 mg/glove max

PROTEIN CONTENT:

ARPL VALUE	FDA REQUIREMENT
80 +/- 20 ppm	200 ppm max.

MOISTURE CONTENT:

IDDI	" " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " "
TT / Y 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 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	1207
9 80%.	value tixed
max	All

BIOCOMPATIBILITY:

ARPL GLOVE	FDA REQUIREMENT
Biologically Compatible	Biologically Compatible

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8.0. Performance Data:

The performance test data of the powder free surgical gloves manufactured by Brightway Gloves Pvt.Ltd is given below.

Measured Parameters of Latex
Surgeon's gloves (Powder free)
manufactured by Brightway Gloves
Pvt.Ltd.,
Characteristics	SIZE	Value
1. Length	5 ½	270 – 272 mm
	6	270 – 272 mm
	6 ½	270 – 272 mm
	7	270 – 272 mm
	7 ½	270 – 272 mm
	8	270 – 272 mm
	8 ½	270 – 272 mm
	9	270 – 272 mm
2. Width	5 ½	68 mm
	6	73 mm
	6 ½	79 mm
	7	87 mm
	7 ½	92 mm
	8	103 mm
	8 ½	106 mm
	9	112 mm

1. Thickness at cuff , Palm and finger tip of all the size is 0 .12, 0.16 and 0.19 mm.

PHYSICAL PROPERTIES:

Characteristics	Before Ageing	After Ageing
Tensile Strength	27 mpa	20 mpa
Elongation at break %	850%	750%
Modulus at 500 %elongation.	3 mpa	-

Image /page/3/Picture/7 description: The image is 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, block letters. The stamp appears to be black ink on a white background. The image is slightly blurry, but the text is still legible.

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PAGE NO : 79

PERFORMANCE REQUIREMENT:

Characteristics	Relateddefects	LEVEL	AQL
Sterility	Fails sterility	As per IndianPharmacopeias
Freedom fromHoles	Holes	S4	1.5
Dimension	Width ,LengthThickness.	S2	4
PhysicalProperty	Tensilestrength,Elongation atbreak beforeand afterageing.	S2	4

POWDER CONTENT: 1 + /- 1 mg per Glove

PROTEIN CONTENT: 80 +/- 20 ppm

MOISTURE CONTENT: 0.8 % max

BIOCOMPATABILITY: Biologically Compatible

Clinical Data NA ・・
CONCLUSION OF PERFORMANCE TEST DATA:

The Powder free Surgeon's gloves manufactured by Brightway Gloves Pvt Ltd

Meet or exceed the ASTM D3577 -
Meet FDA Pin hole Requirement. -
Meet labeling claim as shown by the data in 6

11. ANY OTHER INFORMATION:

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol composed of three curved lines, representing the department's mission to protect the health of all Americans. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the symbol.

MAY 2 2 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K014283

Trade/Device Name: Sterile Latex Surgeons Glove ( Powder Free ) Regulation Number: 878.4460 Regulation Name: Surgeons Glove Regulatory Class: I Product Code: KGO Dated: March 23, 2002 Received: April 11, 2002

Dear Mr. N. 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.

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Page 2 - Mr. N. 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

Enclosure

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3.0 INDICATIONS FOR USE:

BRIGHTWAY GLOVES PVT.LTD. APPLICANT :

KO14283 510(K) No.

DEVICE NAME

INDICATIONS FOR USE:

Powder free Surgeon's glove is a sterile powder free medical device intended to be worn by operating room personnel to protect a surgical wound from contamination.

Olin S. Lin

(Division Sign-Off) Division of Oigh-Off)
Division of Dental, Infection Control,
Frid General Hospital Dowis ் General Bental, Infection O
O(k) Number (k) Number

Image /page/7/Picture/9 description: The image shows a circular stamp with the words "HIGHWAY GLOVES PVT. LTD." written around the edge. In the center of the stamp, the word "NAGERCOIL" is written in block letters. The stamp appears to be black and white and has a slightly worn or used look.

Regulation Number and Section

§ 878.4460 Non-powdered surgeon's glove.

(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).