Predicate Devices

79KGO

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical properties and sterility of surgical gloves, with no mention of AI or ML.

Therapeutic

No
The device is a surgeon's glove, which is intended to protect a surgical wound from contamination, not to provide therapy or treatment.

Diagnostic

No

Explanation: The device, a Surgeon's Glove, is intended to protect a surgical wound from contamination, not to diagnose a condition or disease. The performance studies and key metrics listed describe the physical properties and quality of the gloves themselves, not their diagnostic capabilities.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical product (Surgeon's Gloves) made from Natural Rubber Latex and includes performance studies related to physical properties and material characteristics, not software functionality.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the gloves are "intended to be worn by operating room personnel during surgery to protect a surgical wound from contamination." This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
Device Description: The description details the material (Natural Rubber Latex) and standards it meets (ASTM D 3577 - 91), which are relevant to the physical properties and safety of a glove, not a diagnostic assay.
Performance Studies and Key Metrics: The performance studies and key metrics focus on the physical characteristics of the glove (tensile strength, elongation, freedom from holes, dimensions, etc.) and biological compatibility. These are measures of the glove's integrity and safety for use as a barrier, not diagnostic performance metrics like sensitivity, specificity, or AUC.
Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition.

In summary, the device is a physical barrier intended for protection during surgery, which falls under the category of a medical device, but not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes (comma separated list FDA assigned to the subject device)

KGO

Device Description

Class 1- Surgeon's Gloves (Pre-Powdered) 79KGO that meets all the requirements of ASTM D 3577 - 91.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

operating room personel / Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The Performance Test Data of the Surgeon's Gloves manufactured by SRI ANUSHAM RUBBER INDUSTRIES PVT. LIMITED is given here-under:
Length values for sizes 5.5 to 9 are 270mm to 270-272mm.
Width values for sizes 5.5 to 9 are 68mm to 112mm.
Thickness at cough, palm and finger of all the sizes is 0.12, 0.16 and 0.19mm.

Physical Properties:
Tensile Strength: 29 mpa (Before ageing), 22 mpa (After Ageing)
Elongation at break %: 850% (Before ageing), 800% (After Ageing)

Inspection Level of AQL:
Sterility: Fails Sterility, Level: As per IP
Freedom from holes: Holes, Level: S4, AQL: 1.5
Dimensions: Length, Width & Thickness, Level: S2, AQL: 4
Physical Properties: Tensile Strength, Elongation at Break before & after aging, Level: S2, AQL: 4

POWDER CONTENT: 120 +/- 20mg per glove
PROTEIN CONTENT: 80 +/- 20 ppm
MOISTURE CONTENT: 0.7% maximum
BIO-COMPATABILITY: Biologically Compatible

Conclusion:
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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Class 1- Surgeon's Gloves (Pre-Powdered) 79KGO

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

0

| | SRI ANUSHAM RUBBER INDUSTRIES
PRIVATE LIMITED
100% EXPORT ORIENTED UNIT | TEL: 91 4652 33091
FAX: 91 4652 32871
TLX: 436 209 SIVA IN | Pioneer Manikandan Buildings
Vadasery, 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) LTD
PIONEER MANIKANDAN BUILDINGS
VADASERRY, NAGERCOIL-629001
TAMIL NADU , S.INDIA
PHONE	: + 91 4652 33091
FAX	: + 91 4652 32871
CONTACT PERSON	: MR. N.PARAMASIVAN
MANAGING DIRECTOR
DEVICE TRADE NAME	: NIL
3.	COMMON NAME : Surgeon's Glove
4.	LEGALLY MARKETED DEVICE TO WHICH
COMPANAY CLAIMING EQUIVALENCE :
	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.
5.	DESCRIPTION OF THE DEVICE:
	Class 1- Surgeon's Gloves (Pre-Powdered) 79KGO
that meets all the requirements of
ASTM D 3577 - 91.
6	INTENDED USE OF THE DEVICE:
	Surgeon's glove is a medical device intended to be worn by
operating room personel to protect a surgical wound from
contamination.

こ。
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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 Latex
Surgeon's Gloves Manufactured
by SRI ANUSHAM RUBBER INDUS-
TRIES PRIVATE LIMITED | | | ASTM D 3578
Requirement for
Latex Surgeon's
Glove |
|------------------------------------------------------------------------------------------------------------------------|------|-----------|------------------------------------------------------------|
| 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

.

62

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 at
Break %	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	Width
Length
Thickness	S2	S4	4	4
Physical Property	Tensile Strength
Elongation at Break
before & after
ageing.	S2	S2	4	4

63

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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 first
FDA 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 fixed
E 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 FO
FDA 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 |

t

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 Gloves
manufactured by SRI ANUSHAM RUBBER INDUSTRIES

PRIVATE 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.

65

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 per
IP
Freedom from holes	Holes	S4	1.5
Dimensions	Length,Width &
Thickness	S2	4
Physical Properties	Tensile Strength
Elongation at Break
before & 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.

66

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)

OR

Over-The-Counter Use X

(Optional Format 1-2-96)