Powder free Surgeon's glove is a sterile powder free medical device intended to be worn I oncer free bargen ersonnel 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

Here's a summary of the acceptance criteria and the study for the Shiva Medicare Limited Powder-Free Surgeon's Glove, as derived from the provided document:

This document describes the performance of a medical device, specifically a "Powder free Surgeon's Glove" manufactured by Shiva Medicare Limited, and its adherence to the ASTM D3577 standard. The primary goal of the submission appears to be demonstrating substantial equivalence to a legally marketed predicate device (Class I Surgeon's Glove (Powder free) 79KGO that meets all the requirements of ASTM D3577).

1. Table of Acceptance Criteria and Reported Device Performance:

Characteristic	Acceptance Criteria (ASTM D3577 Requirement)	Reported Device Performance (SML Value)	Meets Criteria?
Dimensions
Length (various sizes)	245 mm minimum (for 5.5) / 265 mm minimum	270-272 mm	Yes
Width (various sizes)	+/- 6 mm of specified nominal width	68-112 mm (within tolerance for each size)	Yes
Thickness (Cuff)	0.1 mm minimum	0.12 mm	Yes
Thickness (Palm)	0.1 mm minimum	0.16 mm	Yes
Thickness (Fingertip)	0.1 mm minimum	0.19 mm	Yes
Physical Properties (Before Ageing)
Tensile Strength	24 mpa	27 mpa	Yes (Exceeds)
Elongation at break %	750%	850%	Yes (Exceeds)
Modulus at 500% elongation	5.5 mpa (max)	3 mpa	Yes (Below max)
Physical Properties (After Ageing)
Tensile Strength	18 mpa min	20 mpa	Yes (Exceeds)
Elongation at break %	560% min	750%	Yes (Exceeds)
Performance Requirements
Sterility	As per USP*	As per IP* (Indian Pharmacopea)	Yes (Equivalent standard used)
Freedom from Holes	S4 (AQL 1.5)	S4 (AQL 1.5)	Yes
Dimension	S2 (AQL 4)	S2 (AQL 4)	Yes
Physical Property	S2 (AQL 4)	S2 (AQL 4)	Yes
Powder Content	Not explicitly stated in D3577	< 2 mg/glove max (Implicit from "Powder free")	Yes
Protein Content	Not explicitly stated in D3577	80 +/- 20 ppm	Yes
Moisture Content	Not explicitly stated in D3577	0.8% max	Yes
Biocompatibility	Biologically Compatible	Biologically Compatible	Yes

*Note on Sterility: While the ASTM D3577 requirement for sterility is "As per USP", Shiva Medicare Limited states "As per IP (Indian Pharmacopea)". The submission would need to demonstrate that the Indian Pharmacopea standard is equivalent to or more stringent than USP for this characteristic. The FDA's acceptance of the 510(k) suggests this was deemed acceptable.

2. Sample Size and Data Provenance:

Test Set Sample Size: The document does not explicitly state the specific number of gloves used for each test (e.g., number of gloves for length, width, tensile strength, or freedom from holes). However, AQL (Acceptable Quality Level) levels like S2 and S4 are mentioned, which imply a statistical sampling plan was used according to ISO 2859-1 (likely MIL-STD-105E or its commercial equivalents like ASTM D3577 Appendix X2 and X3). The AQLs (1.5 for holes, 4 for dimensions and physical properties) indicate the acceptable batch quality.
Data Provenance: The data is reported by Shiva Medicare Limited, an Indian manufacturer. The context (510(k) submission to FDA) indicates this data was generated to support market clearance in the USA. The data is retrospective, as it's being presented for a device that has already undergone testing for market application.

3. Number of Experts and Qualifications for Ground Truth:

Not applicable. This device is a surgical glove, and its performance is evaluated against objective, measurable physical and chemical properties defined by a recognized standard (ASTM D3577). The ground truth is the scientific measurement of these properties, not subjective expert opinion.

4. Adjudication Method for the Test Set:

Not applicable. Evaluation relies on objective measurements against a standard, not expert consensus. Quality control aspects like "Freedom from Holes," "Dimension," and "Physical Property" follow AQL (Acceptable Quality Level) methods, which involve statistically sampling batches and passing/failing based on the number of defects found. This is a statistical process, not an adjudication process by human experts.

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

Not applicable. This device is a surgical glove, not an AI-assisted diagnostic tool or an imaging device that involves human readers or interpretation.

6. Standalone (Algorithm Only) Performance Study:

Not applicable. This device is a physical product (surgical glove), not an algorithm or software. Its performance is inherent in its physical and chemical properties.

7. Type of Ground Truth Used:

The ground truth used is primarily objective physical and chemical measurements compared against established industry standards (ASTM D3577) and regulatory requirements (e.g., sterility per Indian Pharmacopea/USP, biocompatibility per FDA requirements).

8. Sample Size for the Training Set:

Not applicable. This is a physical device, not an AI model requiring a training set.

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

Not applicable, as there is no training set for a physical surgical glove. The "ground truth" for ensuring the glove's quality is established through adherence to manufacturing processes and quality control testing that aims to meet the specified standards.

Summary

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AUG | | | 1998

Image /page/0/Picture/1 description: The image shows a close-up of handwritten numbers and a letter. The numbers "98" and "2586" are visible, along with the letter "K". A horizontal line is drawn beneath the numbers, possibly indicating a total or a separation of values. The handwriting appears to be done with a thick marker or pen, giving the characters a bold and somewhat rough texture.

Image /page/0/Picture/2 description: The image shows a logo with a triangular shape at the top and the word "SHIV" written below it. The triangle is filled with a dark color, and there is a white letter "S" inside the triangle. The word "SHIV" is written in bold, uppercase letters.

:17

510K SUMMARY as required by: 807.92( c )

1.0 APPLICANT

NAME	M/s. SHIVA MEDICARE LIMITED
ADDRESS	A 15, 16, 17(PART)MADRAS EXPORT PROCESSINGZONEKADAPERI, TAMBARAM,CHENNAI 600 045.INDIA.
PH.NO.	: 91-44-2368011/2368322/2362656/2362657.
FAX NO	: 91-44-2368327
EMAIL	: shivam@md2.vsnl.net.in

CONTACT PERSON: MR. SATISH JAIN EXECUTIVE DIRECTOR.

DEVICE TRADE NAME : NIL

.. Surgeon's Glove COMMON NAME

: 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.
1. DESCRIPTION OF THE DEVICE :

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

Intended use of the Device: 6.0

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 logo for Shiva Medicare LTD. The logo features a black cross with the word "MEDICARE" written diagonally across it. Below the cross is a circular seal with the words "SHIVA MEDICARE LTD" around the edge and "Madras-600 045" in the center.

Shiva Medicare Limited

(A 100% Export Oriented Unit)

Registered Office & Works : A 15-17. M.E.P.Z., Kadaperi, Tambaram, Chenna1 - 600 045 (INDIA) Phones : 044/2368011/2368322 EMAIL: Shivani @md2.vsnl-net.in Telefax : 091-44-2368327. Grams : "SHIVMEDI" Corporate Office : 808, Pragaii Tower, 26, Rajendra Place, New Delhi - 110 008 (INDIA) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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7.0 Technological characteristics of the device compared to predicate device.

Measured Parameters of LatexSurgeon's gloves (Powder free)manufactured by Shiva Medicare 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	SML Value	ASTMD3577Requirement	SML 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/6 description: The image shows a circular stamp with the words "AAIHA MEDICARE LTD" around the outer edge. Inside the circle, the text "Madras-600 045" is visible. The stamp appears to be somewhat faded or worn, giving it a vintage or official document-like appearance.

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ERFORMANCE REQUIREMENT:

Characteristics	Relateddefects	Level followedBySML	Level Asper ASTMD 3577	AQL followed	AQL as per ASTMD3577.
Sterility	Fails sterility	As per IP*	As perUSP*.	NA	NA
Freedom fromHoles	Holes	S4	S4	1.5	1.5
Dimension	Width ,LengthThickness.	S2	S2	4	4
PhysicalProperty	Tensilestrength ,Elongation atbreak beforeand afterageing	S2	S2	4	4

IP – INDIAN PHARMACOPEA

OWDER CONTENT

CIT 57ﻟSTATUTE OF COLUMN	ARFOURFMENTA C'T'T
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PROTEIN CONTENT:

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MOISTURE CONTENT:

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BIOCOMPATABILITY:

SML GLOVE	FDA REQUIREMENT
Biologically Compatible	Biologically Compatible

Image /page/2/Picture/11 description: The image shows a circular stamp with the text "SHIVA MEDICARE LTD" around the border. In the center of the stamp, the text "Madras-600 045" is visible. The stamp appears to be of low quality, with some blurring and distortion.

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8.0. Performance Data:

The performance test data of the powder free surgical gloves manufactured by Shiva Medicare Limited is given below.

Measured Parameters of Latex
Surgeon's gloves (Powder free)
manufactured by Shiva Medicare 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/6 description: The image shows a circular stamp with the text "SHIVA MEDICARE LTD" around the outer edge. Inside the circle, the text "Madras-600 045" is printed. The text is in a simple, sans-serif font and is arranged in a way that it fills the circular space effectively. The stamp appears to be somewhat worn, with some parts of the text slightly faded or smudged.

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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

NA 9. Clinical Data :

CONCLUSION OF PERFORMANCE TEST DATA:

The Powder free Surgeon's gloves manufactured by Shiva Medicare Limited

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/14 description: The image shows a circular seal with the text "AHIA MEDICARE LT" around the outer edge. Inside the circle, the text "Madras-600 045" is printed. The text is in a simple, sans-serif font and is arranged to fit within the circular shape of the seal. The seal appears to be a stamp or an official mark, possibly from a medical or healthcare-related organization located in Madras (now Chennai), India.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of a human figure, represented by three overlapping profiles, with a wing-like shape extending from the head.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG | | 1998

M/s. Shiva Medicare Ltd. C/O Mr. James F. Logan Medical Reports Exchange 314 N Huntet Street Baltimore, Maryland 21202

Re : K982586 Sterile Powder-Free Surgical Glove, Trade Name: Disposable Regulatory Class: I Product Code: KGO July 24, 1998 Dated: Received: July 24, 1998

Dear Mr. Logan:

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 qeneral 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 Requlations, 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 the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 2 - Mr. Logan

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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro 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,

S. Dutram for

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:

APPLICANT	SHIVA MEDICARE LIMITED
510(K) No.	K98 2586
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 I oncer free bargen ersonnel to protect a surgical wound from contamination.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Qim S. L
Division Sign. 280

Division Sign-( iff) Division of Der. Infection Control, ind General Hospital Devices "10(k) Number

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use X

(Optional Format 1-2-9

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).