Latex examination glove (Powder free) is a Powder free device 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 Latex ( Powder free) 80LYY that meets all 'the requirements of ASTM D3578- 95.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Shiva Medicare Limited Latex Examination Gloves (Powder free):

1. Table of Acceptance Criteria and Reported Device Performance

Characteristic	Acceptance Criteria (ASTM D3578)	Reported Device Performance (SML Value)	Meets Criteria?
Length
EX-S	220 mm minimum	235-240 mm	Yes
S	220 mm minimum	235-240 mm	Yes
M	230 mm minimum	235-240 mm	Yes
L	230 mm minimum	235-240 mm	Yes
Width
EX-S	70 +/- 6 mm	70 mm	Yes
S	80 +/- 6 mm	82 mm	Yes
M	95 +/- 6 mm	93 mm	Yes
L	111 +/- 6 mm	107 mm	Yes
Thickness	0.08 mm minimum	0.10 mm	Yes
Tensile Strength
Before Ageing	14 mpa min	20 - 22 mpa	Yes
After Ageing	14 mpa min	18 - 20 mpa	Yes
Elongation at Break %
Before Ageing	700% min	750 - 850%	Yes
After Ageing	500% min	700-800%	Yes
Freedom from Holes	AQL 4	AQL 1.5	Yes (Better)
Dimension	AQL 4	AQL 4	Yes
Physical Property	AQL 4	AQL 4	Yes
Powder Content	Not explicitly stated (implied "Powder-free")	1 +/- 1 mg per glove	Yes
Protein Content	"value not fixed"	80 +/- 20 ppm	N/A (meets SML reported value)
Moisture Content	Not explicitly stated	0.8% max	Yes
Biocompatibility	Biologically Compatible	Biologically Compatible	Yes

Summary of Device Performance: The Shiva Medicare Limited Latex Examination Gloves (Powder free) meet or exceed all the specified acceptance criteria from ASTM D3578-95 and FDA pinhole requirements, as reported in the Conclusion of Performance Test Data.

2. Sample size used for the test set and the data provenance

Sample Size: Not explicitly stated. The document refers to "Performance test data of the powder free examination glove manufactured by Shiva Medicare Limited" but does not detail the number of units tested for each characteristic. It mentions AQL (Acceptance Quality Limit) levels (S4, S2) which implies a sampling plan, but the specific sample sizes used per test are not provided.
Data Provenance: The data is generated by Shiva Medicare Limited, located in India (Madras Export Processing Zone, Chennai). The data is prospective as it's presented as the performance of the manufactured device tested against established standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. This study is a performance test of a medical device against established industry standards (ASTM D3578-95) and regulatory requirements (FDA pinhole requirement). Ground truth here is defined by these pre-existing technical specifications, not by expert consensus on individual "cases" or "images."
There were no "experts" establishing a case-by-case ground truth in the traditional sense of a diagnostic study. The "ground truth" is the published standard.

4. Adjudication method for the test set

Not Applicable. As explained above, this is a product performance test against predefined technical standards. There is no adjudication of findings between multiple reviewers as would be seen in clinical image interpretation studies. The measurements are objective physical properties.

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

No. This is a performance study for a physical medical device (gloves), not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant and was not conducted.

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

No. This is a performance study for a physical medical device (gloves), not an algorithm. This concept does not apply.

7. The type of ground truth used

The ground truth used is a combination of:
- Expert Consensus/Standard: The established international standard ASTM D3578-95 for Latex Examination Gloves. ASTM standards are developed through a consensus process involving experts in the field.
- Regulatory Requirement: "FDA Pinhole Requirement."

8. The sample size for the training set

Not Applicable. This is a performance study for a physical medical device (gloves), not a machine learning model. Therefore, there is no "training set" in this context. The product is manufactured and then tested to ensure it meets specifications.

9. How the ground truth for the training set was established

Not Applicable. As there is no training set for a machine learning model, this question does not apply.

Summary

{0}------------------------------------------------

AUG | | 1998

K982579

Image /page/0/Picture/2 description: The image shows a logo with a stylized letter 'S' inside a triangle. The word 'SHIVA' is printed in bold, sans-serif font directly below the triangle. The logo is black and white.

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

NAMEADDRESS	M/s. SHIVA MEDICARE LIMITEDA 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 JAINEXECUTIVE DIRECTOR.
3. DEVICE TRADE NAMECOMMON NAME	: NIL: Patient Examination Glove (Powder free)

Legally marketed device to which the company claiming equivalence: 4. Class I Patient Examination Gloves Latex ( Powder free) 80LYY that meets all the requirements of ASTM D3578 - 95.

DESCRIPTION OF THE DEVICE :

Class I Patient Examination Gloves Latex ( Powder free) 80LYY that meets all 'the requirements of ASTM D3578- 95.

Intended use of the Device:

Latex examination glove (Powder free) is a Powder free device intended for medical purpose that is worn on the examiners hand or finger to prevent contamination between patient and examiner.

Image /page/0/Picture/11 description: The image shows the logo for Shiva Medicare Limited. The text "Shiva Medicare Limited" is written in a large, bold font. Below the company name, it says "100% Export Oriented Unit" in a smaller font. There is also a medical cross symbol on the left side of the image.

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

{1}------------------------------------------------

7.0 TECHNOLOGICAL CHARACTERSTICS OF THE DEVICE COMAPARED TO PREDICATE DEVICE.

Measured Parameters of Latex		ASTM D3578
Examination gloves (Powder free)		Requirement for
manufactured by Shiva Medicare Ltd.,		Latex Examinationglove (Powder free)
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 3578 REQUIREMENT	SML VALUE	ASTD 3578 Requirement
Tensile Strength	20 - 22 mpa	14 mpa min	18 - 20 mpa	14 mpa min
Elongation at break %	750 - 850%	700% min	700-800%	500% min

SML - SHIVA MEDICARE LIMITED

Image /page/1/Picture/5 description: The image shows a circular stamp with the text "SRIYA MEDICARE LTD." around the outer edge. Inside the circle, the text "Madras-600 045" is printed. The stamp appears to be black ink on a white background and is slightly faded, giving it a vintage or official document appearance.

{2}------------------------------------------------

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

A A 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4No. orTT I Y Y Y Y Y'T	- - DEAL IDEN TIDEN - -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
and and a commentsS TH Ynumer---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------of control of the proport division, comprehensive, and theNo. of Cattle & F. Marsh ofCompany and can and	00170And Annual Property of Children Annual Controller Company Company Company Comparis Comments of Children Comments of Children Comments of Children Comments of Children Comment

A A 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4No. orTT I Y Y Y Y Y'T

- - DEAL IDEN TIDEN - -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

and and a commentsS TH Ynumer---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------of control of the proport division, comprehensive, and theNo. of Cattle & F. Marsh ofCompany and can and

00170And Annual Property of Children Annual Controller Company Company Company Comparis Comments of Children Comments of Children Comments of Children Comments of Children Comment

PROTEIN CONTENT:

www.banks.com/processories/article/ship/article/ship/spares/article/relation/relation/relation	REOUTREMENT
SML VALUE	1917
0000pom00------------------------------------------------------------------------------------------------------------------------------------------------------------------------------condidate dell'Annual	talue not fixed.

MOISTURE CONTENT:

A should a free a marge of the many of the many of the many of the comments of the comments ofCAT ATTA THE THE WATERDIVI	Add About AdministrationA Arranger program agains and control and the bases of the below the beginner of the company of the company of the company of the company of the company of the company of theDEALTHENCEMENTT11
0.8% max	t
www.balable.com/shares/articles/articles/articles/articles/articles/articles/articles/articles/articles/articles/articles/articles/articles/articles/	valne
Supportunities Concession Company Company Company of the Artist of the Artists of the Artistics of the Artistics of the Article of the Article of	tixed
STATUTE OF THE PERSONAL PROPERTY OF CHARGE OF CHARGE OF CHARGE OF CHARGE OF CHARGE OF CHARGE OF CHARGE OF CHARGE OF CHEARTH AND THE OFFICE AND THE OFFICE AND THE OFFICE OF CH	while and the first program and and decided dealers and any and and and of the commended to the commended
Comments of the count of the contract and any and any and any and any and	A Company Company Company Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Come Compares

BIOCOMPATABILITY:

SML GLOVE	FDA REQUIREMENT
Biologically Compatible	Biologically Compatible

Image /page/2/Picture/10 description: The image shows a circular stamp with the text "SRIKA MEDICARE LTD." around the outer edge. Inside the circle, the text "Madras - 600 045." is printed. The stamp appears to be a low-resolution scan or photocopy, as the text and lines are somewhat blurred and pixelated.

{3}------------------------------------------------

Performance Data: 8.0

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

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	20 - 22 mpa	18 - 20 mpa
Elongation at break %	750-850%	700-800%

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

Image /page/3/Picture/7 description: The image shows a circular stamp with the text "SRIVA MEDICARE LTD." around the outer edge. Inside the circle, the text "Madras-600 045" is visible. The stamp appears to be somewhat faded or of low resolution, giving it a worn or vintage look. The text is arranged in a way that follows the circular shape of the stamp.

{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 "

7. CONCLUSION OF PERFORMANCE TEST DATA:

The Powder free examination gloves manufactured by Shiva Medicare Limited

Meet or exceed the ASTM D3578 ﺳﮯ
Meet FDA Pin hole Requirement. -
Meet labelling claim as shown by the data in 6 -

8. ANY OTHER INFORMATION:

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

Image /page/4/Picture/12 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 present. A star symbol is located at the bottom of the stamp.

{5}------------------------------------------------

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 stylized depiction of an eagle or bird-like figure, composed of three curved lines that suggest wings or feathers. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

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: K982579 Latex Examination Gloves Powder-Free Trade Name: Requlatory Class: I Product Code: LYY Dated: July 24, 1998 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbrandinq 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

{6}------------------------------------------------

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 requlation (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 general 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. Dutman 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

{7}------------------------------------------------

3.0 INDICATIONS FOR USE:

SHIVA MEDICARE LIMITED APPLICANT : K982579 : 510(K) No. LATEX EXAMINTION GLOVES POWDER FREE DEVICE NAME :

INDICATIONS FOR USE:

Latex Examination Gloves Powder free is a powder free disposable device intended i 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)

Clin S. Lin

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

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use X

(Optional Format 1-2-9

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.