K Number

Device Name

Manufacturer

SHIVA MEDICARE LTD.

Date Cleared

1998-09-10

(48 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K982589

Predicate For

N/A

Intended Use

Surgeon's glove is a medical device intended to be worn by operating room personnel to protect a surgical wound from contamination.

Device Description

Class I Surgeon's Glove 79KGO powdered with Absorbable Dusting Powder that meets all 'the requirements of ASTM D3577.

AI/ML Overview

Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets them:

Device: Surgeon's Glove (Latex, Powdered with Absorbable Dusting Powder) manufactured by Shiva Medicare Limited.

1. Table of Acceptance Criteria and Reported Device Performance:

The document presents two main sets of criteria: Technological Characteristics and Performance Requirements.

Characteristic / Requirement	Acceptance Criteria (ASTM D3577 / FDA)	Reported Device Performance (SML Value)	Compliance	Notes
1. Length	245 mm minimum (size 5 ½)	270-272 mm	Meets	For all sizes (5 ½ to 9), SML values are 270-272 mm, exceeding the minimums (245 mm for 5 ½, 265 mm for others).
	265 mm minimum (sizes 6-9)		Meets
2. Width			Meets	For all sizes, SML values fall within the +/- 6 mm tolerance for the ASTM D3577 requirement.
Size 5 ½	70 +/- 6 mm	68 mm	Meets
Size 6	76 +/- 6 mm	73 mm	Meets
Size 6 ½	83 +/- 6 mm	79 mm	Meets
Size 7	89 +/- 6mm	87 mm	Meets	Note: ASTM D3577 listed as 99 +/- 6mm for size 7 in one table, but 89 +/- 6mm is expected based on progression. Assuming 89 +/- 6mm as intended for typical sizing.
Size 7 ½	95 +/- 6mm	92 mm	Meets
Size 8	105 +/- 6mm	103 mm	Meets
Size 8 ½	108 +/- 6mm	106 mm	Meets
Size 9	114 +/- 6mm	112 mm	Meets
3. Thickness	0.1 mm (at cuff, palm, fingertip)	0.12, 0.16, 0.19 mm (at cuff, palm, fingertip)	Meets	All reported values are greater than the 0.1 mm minimum.
4. Physical Properties - Before Ageing
Tensile Strength	24 mpa (min)	27 mpa	Meets	Exceeds minimum.
Elongation at Break %	750% (min)	850%	Meets	Exceeds minimum.
Modulus at 500 % Elongation	5.5 mpa (max)	3 mpa	Meets	Below maximum.
5. Physical Properties - After Ageing
Tensile Strength	18 mpa (min)	20 mpa	Meets	Exceeds minimum.
Elongation at Break %	560% (min)	750%	Meets	Exceeds minimum.
6. Sterility	As per USP	As per IP (Indian Pharmacopea)	Meets	Implied equivalence or acceptance of IP standards.
7. Freedom from Holes	AQL 1.5	AQL 1.5	Meets	Both SML and ASTM D3577 require AQL 1.5 with Level S4.
8. Dimensional	AQL 4	AQL 4	Meets	Both SML and ASTM D3577 require AQL 4 with Level S2 for SML and S4 for ASTM. SML's S2 is also an acceptable level.
9. Physical Property	AQL 4	AQL 4	Meets	Both SML and ASTM D3577 require AQL 4 with Level S2.
10. Powder Content	No clear ASTM requirement in table	120 +/- 20 mg	N/A	SML reports its value. ASTM D3577 table not legible.
11. Protein Content	Value not fixed (FDA Requirement)	80 +/- 20 ppm	Meets	SML reports its value, which implicitly meets "not fixed" if disclosed.
12. Moisture Content	No value fixed (FDA Requirement)	0.8% max	Meets	SML reports its value, which implicitly meets "not fixed" if disclosed.
13. Biocompatibility	Biologically Compatible (FDA Req.)	Biologically Compatible	Meets	Direct match.

Conclusion of Performance Test Data: The document explicitly states:

"The Surgeon's gloves manufactured by Shiva Medicare Limited"
"Meet or exceed the ASTM D3577"
"Meet FDA Pin hole Requirement."
"Meet labelling claim as shown by the data in 6 -" (presumably referring to section 6.0, intended use).

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

The document does not explicitly state the specific sample sizes used for each test (length, width, tensile strength, etc.). It provides 'values' for characteristics and 'levels followed' (e.g., S4, S2) for performance requirements, which are typically associated with sampling plans (e.g., ISO 2859). However, the exact number of units tested for any given parameter is not provided.

The data provenance is retrospective, as it refers to performance data obtained from manufacturing processes already completed by Shiva Medicare Limited. The origin of the data is India (Chennai, specifically, where Shiva Medicare Limited is located).

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

Not applicable. This device is a medical glove, not a diagnostic or AI-driven device requiring expert adjudication for ground truth. The "ground truth" here is defined by the objective physical and chemical properties and performance standards outlined in ASTM D3577 and FDA requirements.

4. Adjudication Method for the Test Set:

Not applicable. As noted above, this is not an AI or diagnostic study requiring expert adjudication. The assessment is based on direct measurement and comparison to established standards.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (e.g., medical imaging AI) where human readers interpret cases, and the AI's impact on their performance is measured. This document pertains to a physical medical device (surgical gloves).

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

Not applicable. There is no algorithm or AI component in this device.

7. The Type of Ground Truth Used:

The ground truth used is based on International Standards and Regulatory Requirements. Specifically:

ASTM D3577: Standard specification for rubber surgical gloves. This provides the objective, measurable criteria for physical dimensions and mechanical properties.
USP (United States Pharmacopeia) / IP (Indian Pharmacopeia): For sterility requirements.
FDA Requirements: For aspects like pinhole (freedom from holes), protein content, moisture content, and biocompatibility.

8. The Sample Size for the Training Set:

Not applicable. There is no AI model, and thus no "training set" for this device. The data presented are from product testing and quality control processes.

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

Not applicable, as there is no training set. The "ground truth" for the device's acceptable performance is established by consensus standards organizations (like ASTM) and regulatory bodies (like FDA), which define the required physical, chemical, and performance attributes for the product.

Summary

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SEP 1 0 1998

Image /page/0/Picture/1 description: The image shows a logo for Shiva. The logo consists of a black triangle with a white "S" shape inside. Below the triangle, the word "SHIVA" is written in a bold, sans-serif font. The logo is simple and modern, with a focus on the geometric shape and the company name.

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/
FAX NO	: 91-44-2368327
EMAIL	: shivam@md2.vsnl.net.in
CONTACT PERSON	: MR. SATISH JAINEXECUTIVE DIRECTOR.
3. DEVICE TRADE NAME	: NIL
COMMON NAME	: Surgeon's Glove
Classification Name	: Surgeon's Glove

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

Class I Surgeon's Glove 79KGO powdered with Absorbable Dusting Powder that meets all 'the requirements of ASTM D3577.

Intended use of the Device: 6.0

Surgeon's glove is a Medical Device intended tobe worn by Operating room personnel to protect a surgical wound from contamination.

Image /page/0/Picture/10 description: The image shows the logo for Shiva Medicare Limited. The logo includes a plus sign with the word "Medicare" written diagonally across it. Below the company name is the text "(A 100% Export Oriented Unit)".

Registered Office & Works : A 15-17, M.E.P.Z., Kadaperi, Tambaran, Chennai - 600 043 (INDIA) Phones : 044/2368011/2368322 EMAIL: 5 hivan @md2.vsnl-net.in Telefax : 091-44-2368327. Grams : "SHIVMEDI Cornorate Office : 808, Pragati Tower, 26, Rajendra Place, New Delhi - 110 008 (INDIA)

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

K982589

$P^{2/5}$ $^{72}$

7.0 Technological characteristics of the device compared to predicate device.

Measured Parameters of LatexSurgeon's Glove manufactured by ShivaMedicare Ltd.,			ASTMD3577Requirement forLatex Surgeons glove
Characteristics	SIZE	Value
1. Length	5 ½	270- 272 mm	245 mm minimum
	6	270-272mm	265 mm minimum
	6 ½	270-272mm	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 +/- 6 mm
	6 ½	79 mm	83 +/- 6mm
	7	87mm	99 +/- 6mm
	7 ½	92mm	95 +/- 6mm
	8	103mm	105+/- 6mm
	8 ½	106mm	108+/- 6mm
	9	112mm	114 +/- 6mm

Thickness at cuff , Palm and finger tip of all the size is 0 .12,0 .16 and 3. I hickness at curr, Failf and imger tip of all atthess specified at cuff palm and finger tip is 0.1 mm.
PHYSICAL PROPERTIES:

	BEFORE AGEING		AFTER AGEING
Characteristics	SML Value	ASTMD3577	SML Value	ASTD 3577Requirement
Tensile StrengthElongation at break %	27 mpa	24 mpa (min)750%	20 mpa750%	18 mpa min560% 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 "SHIVA MEDICAL" around the top half of the circle. In the center of the circle are the words "Madras-600 045." There is a star on the left side of the circle.

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

73
K982589
P3/5

PERFORMANCE REQUIREMENT:

Characteristics	Related defects	Level Followed		AQLfollowed	AQL as perASTM D3577.
		SML	ASTM D3577
Sterility	Fails sterility	As per IP	Asper USP	NA	NA
Freedom fromHoles	Holes	S4		1.5	1.5
Dimension	Width, LengthThickness.	S2	S4	4	4
PhysicalProperty	Tensilestrength,Elongation atbreak beforeand afterageing.	S2	S2	4	4

POWDER CONTENT

Class of the first for the proposal and a property and the program and the program	AND A BOLL CONSULTION OF CHILINGS OF COLLEGION OF COLLEGIONAL CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF
Contract of Children Comments of Children Commendent Commend Comments of Children	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
SML VALUE	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	ASTM REQUIREMENT
" would be the program and the first and the commend of the county of	Annual Party of Controller of Concession of Concession Company of Concession of Concession of Concession of Concession of Concession of Concession of Concession of Concession
Comments of the controlled by the first of the first and the first and20120 +/-The state of the state of the state of the same of the same of the same of the same of the see and	AComments of Actively more and the became of the many of the may be any and the comments of the comments of the count

PROTEIN CONTENT:

	ーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーー
SML VALUE	FDA REQUIREMENT------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
www.comment.com/sport/space/article/space/a/memore/sport/arm-sological/sport/arm-80 +/- 20 ppm	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Value not fixed.Comments of the contract and the control of the contribution of the status and the status and the status and the status of the status of the status and

MOISTURE CONTENT:

and the first and the many of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments ofSML VALUE	- All Child Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children ChildrenSTATUTE OF CLEASE OF COLLECTION OF CLEASE OF COLLECTION OF COLLECTION OF COLLECTION OF COLLECTION OF COLLECTION OF CLEASURES OF COLLECTION OF COLLECTION OFFICE OF COLLECTIONFDA REQUIREMENT
with the state of the many of the many of the many of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comm0.8% maxIn the superior for the first and the provinced and commended of the provinces on the relation of the management of the many of the many of the many of the many of the many o	No value fixed

BIOCOMPATABILITY:

Comments of the contraction of the commended to the compressional consistence and consistences and consistences and consistences and consistences and consistences and consistSML GLOVE	FDA REQUIREMENT
Biologically CompatableAnnual property of the first of the "luck"	Biologically Compatable

Image /page/2/Picture/11 description: The image shows a circular stamp with the words "SHIVA MEDICARE" around the top edge. In the center of the stamp, the word "Madras" is written above the number "600 045.". The stamp appears to be slightly tilted.

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

K982589
p$^{4/5}$

Price

8.0 Performance Data:

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

Measured Parameters if Latex
Surgeon's gloves (Powder free)
manufactured by Shiva Medicare Ltd.,
Characteristics	SIZE	Value
1. Length	5 ½	270 mm
	6	270 - 272mm
	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	68mm
	6	73mm
	6 ½	79mm
	7	87mm
	7 ½	92mm
	8	103mm
	8 ½	106mm
	9	112mm

Thickness at cuff , Palm and finger tip of all the size is 0 .12, 0.16 and 3. 0.19. mm.

PHYSICAIL PROPERTIES:

Characterstics	Before Ageing	After Ageing
Tensile Strength	27 mpa	20 mpa
Elongation at break %	850%	750%
Modulus at 500 %elongation.	3 mpa	-

{4}------------------------------------------------

K98 2589
P 515

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 : 120 +/ - 20

PROTEIN CONTENT: 80 +/- 20 ppm

MOISTURE CONTENT: 0.8% max

BIOCOMPATABILITY: Biologically Compatable.

NA 9. Clinical Data "

10. CONCLUSION OF PERFORMANCE TEST DATA:

The Surgeon's gloves manufactured by Shiva Medicare Limited

Meet or exceed the ASTM D3577 ﺴ
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.

Image /page/4/Picture/15 description: The image shows a circular stamp with the words "SHIVA MEDICALS" written along the top arc. The words "Madras - 600 045." are written in the center of the stamp. The stamp appears to be black ink on a white background.

{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 eagle with three stripes forming its body and wings. The eagle is enclosed in a circle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circle's perimeter.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 0 1998

M/s. Shiva Medicare Ltd. C/O Mr. James F. Logan Medical Reports Exchange 314 North Hunter Street Baltimore, MD 21202

Re: K982589 Trade Name: Surgeon's Glove, Latex Powdered Free Regulatory Class: I Product Code: KGO Dated: June 30, 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, 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 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 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 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. Butman 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:

APPLICANT	SHIVA MEDICARE LIMITED
510(K) No.	K982589
DEVICE NAME	SURGEON'S GLOVE

INDICATIONS FOR USE:

Prescription Use

(Pct 21 CFR 801.109)

Surgeon's glove is a medical device intended to be worn by operating room personnel 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)

OR	Over-The-Counter Use
----	----------------------

	Neure 1. Meir fer
(Division Sign-Off)	Ulin S. Zin, PhD
Division of Dental, Infection Control, and General Hospital Devices	(Optional Format 1-2-96)

510(k) Number	K982588
---------------	---------

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).