Surgeon's glove (powdered) is a sterile medical device made of natural latex intended to be worn by operating room personnel to protect a surgical wound from contamination and is powdered with absorbable dusting powder USP corn starch as the donning lubricant.

Device Description

Class I Powdered Surgical Glove 79KGO that meets all the requirements of ASTM D3577.

AI/ML Overview

This is an analysis of a 510(k) summary for a medical device, specifically powdered surgeon's gloves. The document primarily focuses on demonstrating substantial equivalence to a predicate device through meeting established performance standards.

Here's the breakdown of acceptance criteria and device performance based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Characteristic	Acceptance Criteria (ASTM D3577 & other standards)	Reported Device Performance (Brightway Gloves Pvt. Ltd.)	Meets Criteria?
Dimensions
Length (5 ½)	245 mm minimum	270-272 mm	Yes
Length (6 to 9)	265 mm minimum	270-272 mm	Yes
Width (5 ½)	70 +/- 6 mm	68 mm	Yes (Within range)
Width (6)	76 +/- 6 mm	73 mm	Yes (Within range)
Width (6 ½)	83 +/- 6 mm	79 mm	Yes (Within range)
Width (7)	99 +/- 6 mm	87 mm	Yes (Within range)
Width (7 ½)	95 +/- 6 mm	92 mm	Yes (Within range)
Width (8)	105 +/- 6 mm	103 mm	Yes (Within range)
Width (8 ½)	108 +/- 6 mm	106 mm	Yes (Within range)
Width (9)	114 +/- 6 mm	112 mm	Yes (Within range)
Thickness (Cuff, Palm, Fingertip)	0.1 mm minimum	0.12 mm (cuff), 0.16 mm (palm), 0.19 mm (fingertip)	Yes
Physical Properties
Tensile Strength (Before Ageing)	24 mpa	27 mpa	Yes
Elongation at break % (Before Ageing)	750%	850%	Yes
Modulus at 500 % elongation (Before Ageing)	5.5 mpa (max)	3 mpa	Yes
Tensile Strength (After Ageing)	18 mpa min	20 mpa	Yes
Elongation at break % (After Ageing)	560% min	750%	Yes
Performance Requirements
Sterility	As per USP	As per IP (Indian Pharmacopeia)	Yes (Assumed equivalent in practice)
Freedom from Holes (AQL)	1.5	1.5 (S4 inspection level)	Yes
Dimension (AQL)	4	4 (S2 inspection level)	Yes
Physical Property (AQL)	4	4 (S2 inspection level)	Yes
Other Properties
Powder Content	150 mg/glove max (on Medium size)	120 +/- 20 mg on size 8 (Implicitly meets for medium if met for size 8)	Yes
Protein Content	200 ppm (max) (FDA Requirement)	80 +/- 20 ppm	Yes
Moisture Content	No value fixed (FDA)	0.8% max	N/A (Device provides stricter internal limit)
Biocompatibility	Biologically Compatible (FDA)	Biologically Compatible	Yes

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

The document does not explicitly state the sample sizes (e.g., number of gloves) used for each specific test. It indicates "BGPL Value" for measured parameters, suggesting the company conducted these tests. The provenance of the data is from Brightway Gloves Pvt. Ltd., located in Tamil Nadu, India. The tests appear to be a retrospective comparison against established standards (ASTM D3577 and FDA requirements) rather than a prospective clinical study.

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

This information is not provided. The "ground truth" for this device is based on compliance with standardized measurements and performance specifications (ASTM D3577, USP, FDA requirements). These standards are developed by expert committees, but the submission does not detail the involvement of specific experts in establishing the ground truth for this particular test set.

4. Adjudication Method for the Test Set

This is not applicable as the compliance is based on objective, standardized measurements against published technical specifications rather than subjective expert assessment requiring adjudication.

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

A MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or interpretive devices where human interpretation of images or data is involved. Surgeon's gloves are a physical product, and their performance is evaluated through material science and physical property tests, not through human reader interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is not applicable. The device is a physical product (surgeon's glove), not an algorithm or AI system. Its performance is inherent to the product itself, not mediated by an AI.

7. Type of Ground Truth Used

The ground truth used is based on established industry standards and regulatory requirements, specifically:

ASTM D3577: Standard Specification for Rubber Surgical Gloves.
USP (United States Pharmacopeia) / IP (Indian Pharmacopeia): For sterility testing.
FDA Requirements: For protein content, moisture content (though no fixed value), and inherent biocompatibility.

These are specifications for physical and chemical properties, not clinical outcomes or expert consensus on a diagnostic interpretation.

8. Sample Size for the Training Set

This is not applicable. As a physical medical device (surgeon's gloves) being assessed for compliance with established performance standards, there is no "training set" in the context of machine learning or AI models. The gloves are manufactured and then tested to ensure they meet specifications.

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

This is not applicable for the same reasons as point 8. There is no concept of a "training set" or "ground truth for a training set" for this type of device submission.

Summary

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MAY 1 4 2002

PAGE NO : 70

510K SUMMARY as required by: 807.92(c)

K014278

1.0 APPLICANT

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

CONTACT PERSON : N. PARAMASIVAN : MANAGING DIRECTOR

1. DEVICE TRADE NAME : NIL
  COMMON NAME : Surgeon's Glove

: Surgeon's Glove (powdered) Classification Name

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

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

6.0 Intended use of the Device:

Powdered Surgeon's glove is a sterile Medical Device intended tobe worn by Operating room personnel to protect a surgical wound from contamination and is powdered with a absorbable dusting powder USP corn starch as a donning Lubricant.

Image /page/0/Picture/15 description: The image is a circular stamp with the words "BRIGHTWAY GLOVES PVT. LTD." written around the edge of the circle. In the center of the circle, the word "NAGERCOIL" is written in large, bold letters. There is a five-pointed star at the bottom of the circle.

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PAGE NO : 71

7.0 Technological characteristics of the device compared to predicate device.

			ASTM D3577
Measured Parameters of Latex			Requirement for
Surgeon's gloves (Powdered)
manufactured by Brightway Gloves			Latex Surgeon's glove(Powder free)
Pvt.Ltd
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)	-	-

. . .

*Brightway Gloves Pvt.Ltd

Image /page/1/Picture/8 description: The image is a circular stamp with the words "BRIGHTWAY GLOVES PVT. LTD." written around the edge. In the center of the stamp, the word "NAGERCOIL" is written in bold letters. There is a small star-like symbol at the bottom of the stamp. The stamp appears to be slightly faded or worn, giving it a vintage look.

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PAGE NO : 72

PERFORMANCE REQUIREMENT:
Characteristics	Related defects	Level followed ByBGPL	Level As per ASTM D 3577	AQL followed By BGPL	AQL as per ASTM D3577.
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 beforeand after ageing.	S2	S2	4	4

IP – INDIAN PHARMACOPEA

POWDER CONTENT

The for the management of the comments of the comments of the comments of the first and the first and the first and BGPL VALUE	The First of the first of the country of the country of the first of the first of the first of the first of the first of the first of the first of the first of the first of tASTM REQUIREMENTThe Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children
The program to Apr 1 a Martin Comments of Act A Comments of Act A Comments of Children Comments of Children Comments of Children Comments of Children Comments of Children Com	l 150 mg/glove max on Medium size
120+/- 20 mg on size 8	Comment of the consistent of the comments of the production of the comments of the comments of the comments of

PROTEIN CONTENT:

BGPL VALUE	FDA REQUIREMENT
80 +/- 20 ppm	200 ppm (max)

MOISTURE CONTENT:

BGPL VALUE	A BRIDGE CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONFDA REQUIREMENT
0.8% max	No value fixedLEL LEARNER BERESS - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

BIOCOMPATIBILITY:

BGPL GLOVE	FDA REQUIREMENT
Biologically Compatible------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	Biologically Compatible

Image /page/2/Picture/11 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, uppercase letters. The stamp appears to be slightly smudged, giving it a worn or used look.

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8.0. Performance Data:

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

Measured Parameters of Latex
Surgeon's gloves (Powdered)
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." around the border. In the center of the stamp is the word "NAGERCOIL" in a bold, sans-serif font. The stamp appears to be somewhat faded or worn, giving it a vintage look.

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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: 120 + /- 20 mg per Glove

PROTEIN CONTENT: 80 +/- 20 ppm

MOISTURE CONTENT: 0.8 % max

BIOCOMPATABILITY: Biologically Compatible

。

Clinical Data

CONCLUSION OF PERFORMANCE TEST DATA:

The Powdered 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.

Image /page/4/Picture/16 description: The image shows a circular stamp with the words "BRIGHTWAY GLOVES PVT. LTD." around the outer edge. Inside the circle is the word "NAGERCOIL" in a smaller circle. There is a star at the bottom of the stamp.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. N. Paramasivan Managing Director Brightway Gloves PVT. LTD. Pioneer Manikandan Buildings Vadasery, Nagar Coil Tamil Nadu. INDIA 629001

Re: K014278

Trade/Device Name: Sterile Latex Surgeon's Glove, Powdered Regulation Number: 878.4460 Regulation Name: Surgeon's Gloves Regulatory Class: I Product Code: KGO Dated: March 23, 2002 Received: April 11, 2002

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.

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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 ail 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Runge

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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PAGE NO : 3

INDICATIONS FOR USE: 3.0

BRIGHTWAY GLOVES PVT.LTD. APPLICANT . Ko14278 : 510(K) No. LATEX SURGEON'S GLOVE POWDERED DEVICE NAME

INDICATIONS FOR USE:

Sunge

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________ 8014279

Image /page/7/Picture/7 description: The image is a circular stamp with the words "OR HIGHWAY GLOVES PVT. LTD." around the perimeter of the circle. Inside the circle is the word "HAGERCOIL" in block letters. The stamp appears to be slightly faded or worn, giving it a vintage look. The text is all in uppercase.

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).