Examination glove (Nitrile) is a disposable device made of Nitrile Latex intended for medical purpose that is worn on the examiners hand or finger to prevent contamination between patient and examiner.

Device Description

Class I Patient Examination Gloves ( Nitrile) 80LZA that meets all 'the requirements of ASTM D3578- 95.

AI/ML Overview

This document describes the performance and acceptance criteria for Shiva Medicare Limited's Powdered Nitrile Examination Gloves.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance:

Characteristics	Acceptance Criteria (ASTM D3578 Requirement)	Reported Device Performance (Shiva Medicare Ltd. Value)
Length (minimum)
EX-S	220 mm min	235-240 mm
S	220 mm min	235-240 mm
M	230 mm min	235-240 mm
L	230 mm min	235-240 mm
Width
EX S	70 +/- 6 mm	70 MM
S	80 +/- 6 mm	82 mm
M	95 +/- 6 mm	93 mm
L	111 +/- 6mm	107 mm
Thickness (minimum)
EX S	0.08 mm min	0.10mm
S	0.08 mm min	0.10mm
M	0.08 mm min	0.10mm
L	0.08 mm min	0.10mm
Physical Properties (Before Ageing)
Tensile Strength	14 mpa min	18 - 20 mpa
Elongation at break %	700% min	750 - 800%
Physical Properties (After Ageing)
Tensile Strength	14 mpa min	16 - 18 mpa
Elongation at break %	500% min	650-700%
Performance Requirement (AQL)
Freedom from Holes	4 (ASTM D3578)	1.5 (SML)
Dimension	4 (ASTM D3578)	4 (SML)
Physical Property	4 (ASTM D3578)	4 (SML)
Powder Content	Not explicitly stated in ASTM D3578 table	120 +/- 20 mg / glove
Protein Content	Not explicitly stated in ASTM D3578 table	30 +/- 10 ppm
Moisture Content	Not explicitly stated in ASTM D3578 table	0.8% max
Biocompatibility	Biologically compatible	Biologically Compatible

2. Sample Sizes Used for the Test Set and Data Provenance:

The document does not explicitly state the sample sizes used for each specific test (e.g., length, width, tensile strength). It refers to the "performance test data" but doesn't detail the sampling plan.

The data provenance is:

Country of Origin: India (Shiva Medicare Limited is located in Chennai, India).
Retrospective or Prospective: Not explicitly stated, but the tests were conducted on gloves manufactured by Shiva Medicare Limited to demonstrate compliance with ASTM D3578-95, suggesting these were contemporary tests on their product.

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

Not applicable. This is a technical performance study of a physical device (gloves), not a diagnostic device requiring expert interpretation of images or clinical data. The "ground truth" is defined by the objective measurement standards outlined in ASTM D3578-95.

4. Adjudication Method for the Test Set:

Not applicable, as this is a physical device performance study. The evaluation is based on direct measurement and adherence to the specified ASTM standard.

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 is not an AI-powered diagnostic device, but a medical glove.

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

Not applicable. This is not an AI-powered device. The device itself (the glove) is what's being evaluated, and its performance is measured directly against technical specifications.

7. The Type of Ground Truth Used:

The ground truth used is objective measurement against established industrial standards, specifically ASTM D3578-95 for examination gloves. These standards define the acceptable ranges for physical properties like dimensions, tensile strength, elongation, and freedom from holes. For Powder, Protein, and Moisture content, specific SML values are provided with no direct ASTM D3578 comparative requirement stated in the table, implying these are internal specifications or generally accepted values. Biocompatibility is stated as "Biologically Compatible" without further detail on the specific tests or standards used, though it implies compliance with relevant biocompatibility testing.

8. The Sample Size for the Training Set:

Not applicable. This is a physical device and does not involve AI or machine learning models that require training data.

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

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

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 5 1999

Shiva Medicare Ltd. C/O Mr. James F. Logan P.O. Box 3721 Crofton, Maryland 21114

Re : K984615 Powdered Nitrile Examination Gloves, Blue Trade Name: Regulatory Class: I Product Code: LZA November 12, 1998 Dated: Received: December 29, 1998

Dear Mr. Logan:

This letter corrects our substantially equivalent letter of November 12, 1998 regarding the error that was made on the address.

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, Druq, 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 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, FDA will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action.

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Page 2 - Mr. Logan

In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your 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 labelinq 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 that the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance
at their toll free number (800) 638/2041 or at (301) 443-6597 or at its internet address

"http://www.fda.qov/cdrh/dsmamain.html".

in.html".

Sincerely

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.	K984615
DEVICE NAME	NITRILE EXAMINATION GLOVES. Powdered, Blue

INDICATIONS FOR USE:

DEVICE NAME

Nitrile Examination Glove is a disposable device made of Nitrile Latex intended for medical purpose, that is worn on the examiners hand or finger to prevent contamination between patient and Examiner.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Pcc 21 CFR 801.109)

510(k) Number

Over-The-Counter Use X

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Dev

(Optional Format 1-2-96)

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

Image /page/3/Picture/1 description: The image shows a logo for "SHIVA". The logo consists of a black triangle with a stylized letter "S" inside it. The word "SHIVA" is written in bold, black letters below the triangle. The logo appears to be simple and modern.

2.0 APPLICANT	K984615

NAME	M/s. SHIVA MEDICARE LIMITED
ADDRESS	A 15, 16, 17(PART)
	MADRAS EXPORT PROCESSINGZONE
	KADAPERI, TAMBARAM,
	CHENNAI 600 045.
	INDIA.
PH.NO.	91-44-2368011/2368322/2362656/2362657

91-44-2368327 .. FAX NO

shivam@md2.vsnl.net.in : EMAIL

CONTACT PERSON : MR. SATISH JAIN EXECUTIVE DIRECTOR.

1. DEVICE TRADE NAME : NIL Blue : Patient Examination Glove (Nitrile), Powdered COMMON NAME

Legally marketed device to which the company claiming equivalence: Class I Patient Examination Gloves ( Nitrile) 80LZA that meets all the requirements of ASTM D3578 - 95.
DESCRIPTION OF THE DEVICE :

Class I Patient Examination Gloves ( Nitrile) 80LZA that meets all 'the requirements of ASTM D3578- 95.

Intended use of the Device:

Image /page/3/Picture/13 description: The image shows a black medical cross with the word "MEDICARE" diagonally across it. The cross is a simple design with thick, uniform lines. The word "MEDICARE" is in a sans-serif font and is also in black. The image appears to be a logo or symbol associated with Medicare.

Shiva Medicare Limited

(A 100% Export Oriented Unit)

Registered Office & Works : A 15-17. M.E.P.Z., Kadaperi, Tambaram, Chennai - 600 045 (INDIA) Phones : 044/2368011/2368322 EMAIL: 5 hivani @md2.vsnl-net.in Telefax : 091-44-2368327. Grams : "SHIVMEDI" Corporate Office : 808, Pragati Tower, 26, Rajendra Place, New Delhi - 110 008 (INDIA) Phones : 011/5762314/5767046, Telex : 031-65886 SHIVA IN Fax 011-5751700

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7.0 TECHNOLOGICAL CHARACTERSTICS OF THE DEVICE COMAPARED TO PREDICATE DEVICE.

Measured Parameters ofExamination gloves (Nitrile)manufactured by Shiva Medicare Ltd.,			ASTM D3578Requirement forExamination glove(Nitrile)
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	SML VALUE *	ASTD 3578REQUIREMENT	SML VALUE	ASTD 3578Requirement
Tensile Strength	18 - 20 mpa	14 mpa min	16 - 18 mpa	14 mpa min
Elongation at break %	750 - 800%	700% min	650-700%	500% min

SML - SHIVA MEDICARE LIMITED

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PERFORMANCE REQUIREMENT:

Characteristics	Related defects	Level followedBy		AQLfollowed bySML	AQL Value asper ASTMD3578.
		SML	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

SML VALUE	ASTM REQUIREMENT
120 +/- 20 mg / glove	-

PROTEIN CONTENT:

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MOISTURE CONTENT:

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Company.----A CORPORATION9 8%112 12------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ANNUAL COLLECTION OF CLAIM AND ALL PROPERTY---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------CONTRACT	----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------******and a local consumer

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BIOCOMPATABILITY:

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---------Biologically (.omnatible	--------------------------. 04omnatible
Property

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8.0 --Performance Data:

The performance test data of the Nitrile examination glove manufactured by Shiva Medicare Limited is given below.

Measured Parameters of
Examination gloves (Nitrile)
manufactured by Shiva Medicare 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

PHY SICAL PROPERTIES

CHARACTERISTICS	Before Ageing	After Ageing
Tensile Strength	18 - 20 mpa	16 - 18 mpa
Elongation at break %	750 - 800%	650-700%

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

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POWDER CONTENT : 120 +/- 20 mg per glove

PROTEIN CONTENT: 30 +/- 10 ppm

MOISTURE CONTENT: .0.8% max

BIOCOMPATABILITY: Biologically Compatible.

NA 9. Clinical Data :

CONCLUSION OF PERFORMANCE TEST DATA: 10.

The Examination gloves (Nitrile) manufactured by Shiva Medicare Limited

Meet or exceed the ASTM D3578 -
Meet FDA Pin hole Requirement. .
Meet labelling 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.

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.