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

The provided text describes the acceptance criteria and performance data for a Powder-Free Surgeon's Glove. The study is a standalone performance study to demonstrate that the device meets established standards.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Characteristic	Acceptance Criteria (ASTM D3577 Requirement unless otherwise specified)	Reported Device Performance (SARI Value)	Pass/Fail
Length (5 ½ size)	245 mm minimum	270-272 mm	Pass
Length (6 size)	265 mm minimum	270-272 mm	Pass
Length (6 ½ size)	265 mm minimum	270-272 mm	Pass
Length (7 size)	265 mm minimum	270-272 mm	Pass
Length (7 ½ size)	265 mm minimum	270-272 mm	Pass
Length (8 size)	265 mm minimum	270-272 mm	Pass
Length (8 ½ size)	265 mm minimum	270-272 mm	Pass
Length (9 size)	265 mm minimum	270-272 mm	Pass
Width (5 ½ size)	70 +/- 6 mm	68 mm	Pass (within range 64-76mm)
Width (6 size)	76 +/- 6 mm	73 mm	Pass (within range 70-82mm)
Width (6 ½ size)	83 +/- 6 mm	79 mm	Pass (within range 77-89mm)
Width (7 size)	99 +/- 6 mm	87 mm	Pass (within range 93-105mm)
Width (7 ½ size)	95 +/- 6 mm	92 mm	Pass (within range 89-101mm)
Width (8 size)	105 +/- 6 mm	103 mm	Pass (within range 99-111mm)
Width (8 ½ size)	108 +/- 6 mm	106 mm	Pass (within range 102-114mm)
Width (9 size)	114 +/- 6 mm	112 mm	Pass (within range 108-120mm)
Thickness (Cuff, Palm, Fingertip)	0.1 mm minimum	0.12 mm (cuff), 0.16 mm (palm), 0.19 mm (fingertip)	Pass
Tensile Strength (Before Ageing)	24 mpa	27 mpa	Pass
Elongation at Break % (Before Ageing)	750%	850%	Pass
Modulus at 500% Elongation (Before Ageing)	5.5 mpa (max)	3 mpa	Pass
Tensile Strength (After Ageing)	18 mpa min	20 mpa	Pass
Elongation at Break % (After Ageing)	560% min	750%	Pass
Sterility	As per USP*	As per IP*	Pass (Implied by meeting IP standards)
Freedom from Holes	AQL 1.5 (S4 Level)	AQL 1.5 (S4 Level)	Pass (Stated to meet AQL)
Dimension	AQL 4 (S2 Level)	AQL 4 (S2 Level)	Pass (Stated to meet AQL)
Physical Property (Tensile strength, Elongation at break)	AQL 4 (S2 Level)	AQL 4 (S2 Level)	Pass (Stated to meet AQL)
Powder Content	Not specified in D3577 section, but stated to be 1 +/- 1 mg per glove	1 +/- 1 mg per Glove	Pass
Protein Content	Not specified in D3577 section, but stated to be 80 +/- 20 ppm	80 +/- 20 ppm	Pass
Moisture Content	Not specified in D3577 section, but stated to be 0.8% max	0.8% max	Pass
Biocompatibility	Not specified in D3577 section, but stated to be Biologically Compatible	Biologically Compatible	Pass

Note: IP (Indian Pharmacopea) and USP (United States Pharmacopeia) are both pharmacopoeial standards for sterility. Meeting IP, along with the claim of meeting or exceeding ASTM D3577, implies acceptable sterility.

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

Sample Size for Test Set: The document does not explicitly state the specific number of gloves tested for each characteristic. It refers to "AQL followed" for various performance requirements, implying a sampling plan was used as per ASTM D3577, but the exact number of units sampled or tested is not provided.
Data Provenance: The data is reported by "Sri.Anusham Rubber Industries Pvt. Ltd." which is located in Nagarcoil, Tamil Nadu, India. The data is retrospective in the sense that it's presented as the results of tests already conducted on their manufactured gloves.

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

This type of information is not applicable to this study. The ground truth for device performance is established based on objective measurements against quantifiable standards (ASTM D3577) rather than expert consensus on interpretations of complex data like medical images.

4. Adjudication Method for the Test Set

This is not applicable as the determination of whether the device meets the criteria is based on objective, quantitative measurements against a predefined standard (ASTM D3577), not on subjective assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human readers (e.g., radiologists interpreting images) and is not applicable to the performance testing of a physical medical device like a surgeon's glove.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance study was done. The document presents the intrinsic performance of the manufactured gloves against established standards (ASTM D3577 and other specific chemical/physical properties) without involving human operators in a comparative effectiveness setting. The "device" in this context is the glove itself, and its performance is assessed directly.

7. The Type of Ground Truth Used

The ground truth used is based on pre-defined, objective performance standards and specifications from ASTM D3577, as well as internal specifications for powder, protein, and moisture content, and biocompatibility. These are quantifiable criteria used to assess the physical, mechanical, and biological properties of the gloves.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical product (surgeon's glove), not an algorithm or a software AI requiring a "training set" in the machine learning sense. The manufacturing process is designed to consistently produce gloves meeting these specifications.

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

This is not applicable for the reason mentioned in point 8.

Summary

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NOV 2 3 1999

K993349

PAGE NO : 75

1. 510K SUMMARY as required by: 807.92( c )

1.0 APPLICANT

NAME

PH.NO. FAX NO

ADDRESS

SRI.ANUSHAM RUBBER INDUSTRIES .. PVT.LTD. PIONEER MANIKANDAN BUILDINGS, VADASERY NAGAR COIL, TAMIL NADU, INDIA - 629001. : 91-4652-33091,32506. : 91-4652-32871

CONTACT PERSON

: N. PARAMASIVAN : MANAGING DIRECTOR

DEVICE TRADE NAME : NIL

COMMON NAME .. Surgeon's Glove

: Powder free Surgcon's Glovc Classification Namc

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.

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/18 description: The image shows a circular stamp with text around the perimeter. The text reads "SRI ANUSIAM RUBBER" along the top curve and "NAGERCO" along the bottom. There is a star symbol on the left side of the stamp.

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PAGE NO : 76

Measured Parameters of LatexSurgeon's gloves (Powder free)manufactured by Sri.Anusham Rubberindustries Pvt. 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	265 mm 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

7.0 Technological characteristics of the device compared to predicate device.

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:

Characteristics	BEFORE AGEING		AFTER AGEING
	SARI Value	ASTMD3577Requirement	SARI 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)	-	-

SARI : SRI. ANUSHAM RUBBER INDUSTRIES

Image /page/1/Picture/8 description: The image shows a partial view of a circular stamp or seal. The text "SRI ANUSHA M RI" is visible along the curved edge of the stamp. The text appears to be slightly faded or worn, giving the stamp a vintage or used appearance. The stamp is black and white.

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PERFORMANCE REQUIREMENT:

PAGE NO : 77

Characteristics	Related defects	Level followed By	Level As per ASTM D 3577	AQL followed	AQL as per D3577.
			SARI
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

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PROTEIN CONTENT:

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MOISTURE CONTENT:

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FOR AND LE PRODUCT CALLERY COLLECTION COLLEGION COLLEGE COLLECTION COLLEGE COLLECTION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGIO------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------IN II WA MANAGE I WA MILE WE KULEN E WA LAND MIL C------------------------------------------------------------------------------------------------------------------------------------------------------------------------------were can prices believe the career ofCalleries Court of Local Labor La	IN IL MINER OR CONNER SIMILE LE LE I------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------CONSULTION CLIFFER CLUB0-00 000 000 11-08-11 100-000------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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A SALE ARRETT CONSULTION AND COLLECTION OF ALL CARRELLERS OF COLLECTION OF COLLECTION OF COLLECTION OF COLLECTION OF COLLECTION OF COLLECTION OF CONSULTION OF CONSULTION OF C.------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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BIOCOMPATABILITY:

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410 00AND AND AND LEASE CARD COLLECTION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLECTION COLLEGIONLAND LEAST LE LEASE & LE LEASE & LE LEASE & LEASE & LEASE & LEASE & LEASE & LEASE & LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST	-12finle

Image /page/2/Picture/12 description: The image shows a circular stamp with text around the perimeter. The text reads "SRI PRABHATHAM RUBBER INDUSTRIES PVT. LTD." The center of the stamp contains the text "NAGERCOIL".

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8.0. Performance Data:

The performance test data of the powder free surgical gloves manufactured by Stri. Anusham Rubber Industries Pvt. Ltd is given below.

Measured Parameters of Latex
Surgeon's gloves (Powder free)
manufactured by Anusham Rubber
Industries 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.
  PHYSICAI. PROPERTIFS:

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 shows a circular stamp with text around the perimeter. The text reads "SRI ANUSHTAN I BBER INDUSTRIES PVT. LTD." with a star symbol. In the center of the stamp, the text "NAGERCOIL" is vertically oriented.

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PAGE NO : 79

PERFORMANCE REQUIREMENT:

Characteristics	Related defects	LEVEL	AQL
Sterility	Fails sterility	As per IndianPharmacopea
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 Sri.Anusham Rubber Industries Pvt Ltd

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

ANY OTHER INFORMATION:

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

Image /page/4/Picture/15 description: The image shows a circular stamp with text around the perimeter and in the center. The text around the perimeter reads "SRI ANUSHAM RUBBER INDUS TRES PVT LTD" with a star on either side of the "D". In the center of the stamp, the text "NAGERCOIL" is printed vertically.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines that suggest the shape of a bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 3 1999

Mr. N. Paramasivan Managing Director SRI Anusham Rubber Industries Private, Limited Pioneer Manikandan Buildings Vadasery, Naqercoil-629001 Tamil Nadu, S. India

Re : K993349 Trade Name: Surgeon's Glove - Powder Free Regulatory Class: I Product Code: KGO September 28, 1999 Dated: Received: October 5, 1999

Dear Mr. Paramasivan:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in

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Page 2 - Mr. Paramasivan

this response to your the Federal Register. Please note: premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in yitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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" (21 CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

thy A. Ulatows Diredtor 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:

APPLICANT	: SRI. ANUSHAM RUBBER INDUSTRIES PVT.LTD.
510(K) No.	: K99 3349
DEVICE NAME	: POWDER FREE SURGEON'S GLOVE

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. r

Image /page/7/Picture/4 description: The image is a circular stamp with text around the perimeter and in the center. The text around the perimeter reads "SRI ANUSHAM RUBBER INDUSTRIES PVT. LTD." with a star symbol. The text in the center reads "NAGERCOIL" in a rotated orientation.

OTC

J. Alitsted

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

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).