K Number

Device Name

Manufacturer

SRI ANUSHAM RUBBER INDUSTRIES PVT., LTD.

Date Cleared

1999-05-21

(164 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

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

Device Description

Class 1- Surgeon's Gloves (Pre-Powdered) 79KGO that meets all the requirements of ASTM D 3577 - 91. Type 1 - Gloves compounded primarily from Natural Rubber Latex.

AI/ML Overview

The device being described is a Surgeon's Glove manufactured by SRI ANUSHAM RUBBER INDUSTRIES PRIVATE LIMITED. The acceptance criteria and performance data are primarily based on the ASTM D3577-91/95 specifications for latex surgeon's gloves.

Here's the breakdown of the information requested:

1. A table of acceptance criteria and the reported device performance

Characteristic	Acceptance Criteria (ASTM D3577-95)	Reported Device Performance (SARI Value)	Result
Dimensions
Length (various sizes)	245 mm minimum (size 5.5), 265 mm minimum (sizes 6-9)	270-272mm (all sizes)	Meets
Width (various sizes)	Varies by size (e.g., 70 +/- 6 mm for 5.5, 114 +/- 6 mm for 9)	Consistent with ASTM ranges (e.g., 68mm for 5.5, 112mm for 9)	Meets
Thickness	0.1mm minimum at cuff, palm, and finger	0.12mm (cuff), 0.16mm (palm), 0.19mm (finger)	Meets
Physical Properties
Tensile Strength (Before Ageing)	24 mpa min.	31 mpa (SARI Value), 29 mpa (Performance Test Data)	Meets
Elongation at Break % (Before Ageing)	750% min.	950-975% (SARI Value), 850% (Performance Test Data)	Meets
Tensile Strength (After Ageing)	18 mpa min.	22 mpa	Meets
Elongation at Break % (After Ageing)	560% min.	850-900% (SARI Value), 800% (Performance Test Data)	Meets
Modulus at 500% Elongation (Before Ageing)	5.5 mpa (max)	3.4 mpa	Meets
Performance Requirements (AQL)
Freedom from Holes	AQL 1.5	AQL 1.5 (SARI)	Meets
Dimensions	AQL 4	AQL 4 (SARI)	Meets
Physical Property	AQL 4	AQL 4 (SARI)	Meets
Other Properties
Powder Content	Not explicitly stated in ASTM, but implied compliance through SARI value. (ASTM D3577-95 typically specifies maximum powder residue)	120 +/- 20 mg per glove (SARI Value for Powder Content)	Meets
Protein Content	FDA Requirement: Value not fixed	80 +/- 20 ppm	Meets (no fixed requirement)
Moisture Content	FDA Requirement: Value not fixed	0.8% (SARI Value/Maximum for Performance Test Data)	Meets (no fixed requirement)
Bio-compatibility	Biologically Compatible (FDA Requirement)	Biologically Compatible	Meets
Sterility	NA (as per SARI)	"Fails Sterility" is a defect, not a performance metric for the device itself (AQL level "As per IP" for SARI, "As per USP" for ASTM is listed). The document doesn't explicitly state the glove is sterile, but rather that sterility failure is a defect.	N/A (implied that if claimed sterile it meets standard, but not explicitly stated as a performance criteria metric)

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

Sample Size: The document does not explicitly state the sample sizes used for each specific test (e.g., number of gloves for tensile strength testing, number of gloves for hole testing). It refers to "SARI Value" and "Performance Test Data," suggesting internal testing by the manufacturer.
Data Provenance: The data is retrospective, generated by SRI ANUSHAM RUBBER INDUSTRIES PRIVATE LIMITED, a company located in Nagercoil, Tamil Nadu, S. India. It represents their internal testing results for the purposes of a 510(k) submission to the FDA.

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

Number of Experts: Not applicable. The ground truth is established by adherence to a recognized international standard, ASTM D3577-91/95, which defines the specifications for surgeon's gloves. The "Pioneer Manikandan Buildings" entity appears to be the manufacturer, not an expert panel for ground truth assessment.
Qualifications of Experts: Not applicable.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Adjudication Method: Not applicable. This type of study does not involve human expert adjudication in the traditional sense. The device's performance is objectively measured against a predefined technical standard (ASTM D3577).

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

MRMC Study: No, a multi-reader multi-case comparative effectiveness study was not done. This is a technical performance study for a physical medical device (surgeon's gloves), not an AI-assisted diagnostic tool.

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

Standalone Performance: Not applicable. This device is a physical product (surgeon's gloves), not an algorithm or software. Its performance is measured directly through physical and chemical tests.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Type of Ground Truth: The ground truth is established by existing regulatory standards and technical specifications, specifically the ASTM D3577-91/95 for latex surgeon's gloves. This standard defines the required physical and chemical properties.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. There is no "training set" in the context of this device's evaluation, as it is not a machine learning model. The manufacturer would have internal quality control and manufacturing processes that produce gloves meeting the specifications, but this isn't a "training set" in the AI sense.

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

Ground Truth for Training Set: Not applicable (as per point 8). The manufacturing process and quality control would be geared towards consistent production of gloves that adhere to the ASTM D3577 standards.

Summary

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

	SRI ANUSHAM RUBBER INDUSTRIESPRIVATE LIMITED100% EXPORT ORIENTED UNIT	TEL: 91 4652 33091FAX: 91 4652 32871TLX: 436 209 SIVA IN	Pioneer Manikandan BuildingsVadasery, Nagercoil-629001.Tamil Nadu, S India.	6
--	-------------------------------------------------------------------------------	------------------------------------------------------------------	-------------------------------------------------------------------------------------	---

MAY 21 1999

K984395

1.0	510K SUMMARY as required by : 807.92(c)
2.0	APPLICANT.
NAME	: SRI ANUSHAM RUBBER INDUSTRIES (P) LTDPIONEER MANIKANDAN BUILDINGSVADASERRY, NAGERCOIL-629001TAMIL NADU , S.INDIA
PHONE	: + 91 4652 33091
FAX	: + 91 4652 32871
CONTACT PERSON	: MR. N.PARAMASIVANMANAGING DIRECTOR
DEVICE TRADE NAME	: NIL
3.	COMMON NAME : Surgeon's Glove
4.	LEGALLY MARKETED DEVICE TO WHICHCOMPANAY CLAIMING EQUIVALENCE :
	Class 1- Surgeon's Gloves (Pre-Powdered) 79KGOthat meets all the requirements ofASTM D 3577 - 91.
	Type 1 - Gloves compounded primarily from Natural RubberLatex.
5.	DESCRIPTION OF THE DEVICE:
	Class 1- Surgeon's Gloves (Pre-Powdered) 79KGOthat meets all the requirements ofASTM D 3577 - 91.
6	INTENDED USE OF THE DEVICE:
	Surgeon's glove is a medical device intended to be worn byoperating room personel to protect a surgical wound fromcontamination.

こ。
『

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

TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO PREDICATE DEVICE. om and end and and ear and ein him me min me me me me une me and min me une me uit me was was was was was was was was was was was was was was was was was was was was was was

Measured Parameters of LatexSurgeon's Gloves Manufacturedby SRI ANUSHAM RUBBER INDUS-TRIES PRIVATE LIMITED			ASTM D 3578Requirement forLatex Surgeon'sGlove
Characteristics	Size	Value	Prescribed
1. Length	5.5	270-272mm	245 mm minimum
	6	270-272mm	265 mm minimum
	6.5	270-272mm	265 mm minimum
	7	270-272mm	265 mm minimum
	7.5	270-272mm	265 mm minimum
	8	270-272mm	265 mm minimum
	8.5	270-272mm	265 mm minimum
	9	270-272mm	265 mm minimum
2. Width	5.5	68mm	70 +/- 6 mm
	6	73mm	76 +/- 6 mm
	6.5	79mm	83 +/- 6 mm
	7	87mm	89 +/- 6 mm
	7.5	92mm	95 +/- 6 mm
	8	103mm	105 +/- 6 mm
	8.5	108mm	108 +/- 6 mm
	9	112mm	114 +/- 6 mm

ri Thickness at Cuff,Palm and Finger. tip of all the sizes is 0.12mm,0.16mm and 0.19mm respectively. As per ASTM D3577-95 the minimum thickness specfied at cough,palm and finger is 0.1mm.
7 .. 0

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

PHYSICAL PROPERTIES

	BEFORE AGEING		AFTER AGEING
CHARACTERISTICS	*SARI VALUE	ASTM D 3577 REQUIREMENT	SARI VALUE	ASTM D 3577 REQUIREMENT
Tensile Strength	31 mpa	24 mpa min.	22mpa	18 mpa min.
Elongation atBreak %	950-975%	750% min.	850-900%	560% min.
Modulus at 500%Elongation	3.4 mpa	5.5 mpa(max)	-	-

Carrier

*SARI - SRI ANUSHAM RUBBER INDUSTRIES FRIVATE LIMITED

PERFORMANCE REQUIREMENT :

Characteristics	Related Defects	Level followed By		AQL followed by SARI	AQL Value as per ASTM D3577
		SARI	As per ASTM D3577
Sterility	Fails Sterility	As per IP	As per USP	NA	NA
Freedom from Holes	Holes	S4		1.5	1.5
Dimensions	WidthLengthThickness	S2	S4	4	4
Physical Property	Tensile StrengthElongation at Breakbefore & afterageing.	S2	S2	4	4

් පිහිටි පිහිටා හා දෙකින් පිහිට

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

POWDER CONTENT :

100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000

	FOR ANY FOR CONTENT OF THE FOR CONSTITUTION OF THE FOR COLLECTION OF CREATING OF CREATING OF CREATING OF CREAT OF CREAT OF CREAT OF CREAT OF CREAT OF CREAT OF CREAT OF CREASE
SARI VALUE	ASTM REQUIREMEN
120 +/-20	144 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 10.

PROTEIN CONTENT:

SARI VALUE	NE LEA LEA LES PRODUCE CALL CAR CAR CAR CAR CAR CAR CAR CAR CAR COLLECTION COLLECTION COLLECTION COLLECTION COLLECTION COLLECTION CARE CREATING CARE CREATING CARA CON CREAT C
The for the first for the part and one for the first and the first and the mean and me me more and can and me me more see many ment me more see more see many ment me more see	FDA REQUIREMENT
80+/-20ppm	Value not fixed(2) [2] [2] [2] [2] [2] [2] [2] [2] [2] [2] [2] [2] [2] [2] [2] [2] [2] [2] [2] [2] [2] [2] [2] [2] [2] [2] [2] [2] [2] [2] [2] [2] [2] [2] [2] [2] [2] [2] [2] [2] [2] [2] [2

MOISTURE CONTENT :

SARI VALUE	suit free new and the first least and the new see and the new seen price for the many and for the first for the first for the first for the first for the first for the firstFDA REQUIREMENT" " the new reas not the case and not new see and may not me and me not me see and may not see and may not the may not not not not not not not not not not not not not not not
0.8%	Value not fixedE MICH EN ENTERES OF FEE SERVET FOR COLLECTION CONTRIVER OF CHE THE THE THE THE FORE THE FINE FOR THE FINE FOR THE FINE FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FINE FOR THE F

BIO-COMPATABILITY

SARI GLOVE	FIFT THE CHIE PER FINE FREE FOR THE FOR THE FOR THE FOR THE FOR THE FOR THE FOR THE FOR THE FOR THE FOR THE FOR THE FOR THE FOR THE FOR THE FOR THE FOR THE FOR THE FOR THE FOFDA REQUIREMENT
The me nee and hear for any for the long may been and on the new the new see and one and one and one and one and one meet the will be fill and the look has not one the line t	Biologically Compatible
Biologically Compatible	THE CHILDER OF THE COLLECTION COLLECTION COLLECTION COLLECTION COLLECTION COLLECTION COLLECTION COLLECTION COLLECTION COLLECTION COLLECTION COLLECTION COLLECTION COLLECTION C

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

日 . മ PERFORMANCE DATA

: 上 The Performance Test Data of the Surgeon's Gloves manufactured by SRI ANUSHAM RUBBER INDUSTRIES PVT. LIMITED is given here-under:

Measured Parameters of Latex Surgon's Glovesmanufactured by SRI ANUSHAM RUBBER INDUSTRIESPRIVATE LIMITED
Characteristics	Size	Value
1. Length	5.5	270 mm
	6	270 - 272 mm
	6.5	270 - 272 mm
	7	270 - 272 mm
	7.5	270 - 272 mm
	8	270 - 272 mm
	8.5	270 - 272 mm
	9	270 - 272 mm
2. Width	5.5	68mm
	6	73mm
	6.5	79mm
	7	87mm
	7.5	92mm
	8	103mm
	8.5	106mm
	9	112mm

ાં છ Thickness at cough ,palm and finger of all the sizes is 0.12, 0.16 and 0.19mm.

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

FHYSICAL PROPERTIES

CHARACTERISTICS	Before ageing	After Ageing
Tensile Strength	29 mpa	22 mpa
Elongation at break %	850%	800%

INSPECTION LEVEL OF AQL

CHARACTERISTICS	RELATED DEFECTS	LEVEL	AQL
Sterility	Fails Sterility	As perIP
Freedom from holes	Holes	S4	1.5
Dimensions	Length,Width &Thickness	S2	4
Physical Properties	Tensile StrengthElongation at Breakbefore & after aging	S2	4

POWDER CONTENT	120 +/- 20mg per glove
PROTEIN CONTENT	80 +/- 20 ppm
MOISTURE CONTENT	0.7% maximum
BIO-COMPATABILITY	Biologically Compatible
9. CLINICAL DATA	Not Applicable

CONCLUSION OF PERFORMANCE OF TEST DATA:

The Surgeon's Gloves manufactured by SRI ANUSHAM RUBBER INDUSTRIES PRIVATE LIMITED;

Meet or exceed the ASTM D3577-95 Specifications
Meet FDA Pin Hole Requirements
Meet Labelling Claim as shown in data under S.No.6

ANY OTHER INFORMATION:

Any other information required by FDA in respect of PRODUCT SAFETY AND EFFECTIVENESS shall be provided on demand.

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

Image /page/6/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 21 1999

SRI Anusham Rubber Industries Pvt. Ltd. C/O Ms. Latha Kumaraswamy Authorised/Designated Agent U.S.A. P.O. Box 5206 Pleasanton, California 94566 U.S.A.

K984395 Re : Surgeon's Gloves Trade Name: Requlatory Class: I Product Code: KGO March 17, 1999 Dated: Received: March 19, 1999

Dear Ms. Kumaraswamy:

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 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. Existinq major requlations 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) requlation (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 requlation 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 the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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

Page 2 - Ms. Kumaraswamy

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 ene 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,

Suser Pungs

Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{8}------------------------------------------------

510(k) Number (if known): Device Name: 2800 Indications For Use:

INDICATIONS FOR USE
APPLICANT	: SRI ANUSHAM RUBBER INDUSTRIES PVT.LTD
510(K) NO	:
DEVICE NAME	: SURGEON'S GLOVES
INDICATIONS FOR USE:
Surgeon's Glove is a medical device intended to be worn by operating room personnel during surgery 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)

Olin S. him

(Division and I 510(k) Nu

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use X

(Optional Format 1-2-96)

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).