K Number
K993349
Device Name
NIL, SURGEON'S GLOVE - POWDER FREE
Date Cleared
1999-11-23

(49 days)

Product Code
Regulation Number
878.4460
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Powder free Surgeon's glove is a sterile powder free medical device intended to be worn by operating room personnel to protect a surgical wound from contamination.
Device Description
Class I Powder free Surgical Glove 79KGO that meets all 'the requirements of ASTM D3577.
More Information

79KGO

Not Found

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

No.
The device is a surgical glove, which is a barrier to protect against contamination, not to treat or cure a disease or condition.

No
The device is a surgical glove, which is a protective barrier, not a tool for diagnosing medical conditions.

No

The device description and performance studies clearly indicate this is a physical surgical glove, not a software-only device.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is to protect a surgical wound from contamination by being worn by operating room personnel. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
  • Device Description: It's described as a Class I Powder free Surgical Glove. Surgical gloves are generally considered medical devices for protection and barrier purposes, not for diagnosis.
  • Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
    • Analyzing samples (blood, urine, tissue, etc.)
    • Detecting or measuring substances in samples
    • Providing information for diagnosis, monitoring, or screening

The performance studies and key metrics listed are related to the physical properties, sterility, and biocompatibility of the glove, which are relevant for a protective medical device, but not for an IVD.

N/A

Intended Use / Indications for Use

Powder free Surgeon's glove is a Powder free Medical Device intended tobe worn by Operating room personnel to protect a surgical wound from contamination.
INDICATIONS FOR USE:Powder free Surgeon's glove is a sterile powder free medical device intended to be worn by operating room personnel to protect a surgical wound from contamination.

Product codes

KGO

Device Description

Class I Powder free Surgical Glove 79KGO that meets all 'the requirements of ASTM D3577.

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 personnel

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 powder free surgical gloves manufactured by Stri. Anusham Rubber Industries Pvt. Ltd is given below.
Measured Parameters of Latex Surgeon's gloves (Powder free) manufactured by Anusham Rubber Industries Pvt.Ltd.,
Characteristics, SIZE, Value

  1. Length, 5 ½, 270-272 mm
    6, 270-272 mm
    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, 68 mm
    6, 73 mm
    6 ½, 79 mm
    7, 87 mm
    7 ½, 92 mm
    8, 103 mm
    8 ½, 106 mm
    9, 112 mm
    Thickness at cuff, Palm and finger tip of all the size is 0 .12, 0.16 and 0.19 mm.
    PHYSICAI. PROPERTIFS:
    Characteristics, Before Ageing, After Ageing
    Tensile Strength, 27 mpa, 20 mpa
    Elongation at break %, 850%, 750%
    Modulus at 500 % elongation., 3 mpa, -
    PERFORMANCE REQUIREMENT:
    Characteristics, Related defects, LEVEL, AQL
    Sterility, Fails sterility, As per Indian Pharmacopea, Not Found
    Freedom from Holes, Holes, S4, 1.5
    Dimension, Width , Length Thickness., S2, 4
    Physical Property, Tensile strength , Elongation at break before and after ageing., S2, 4
    POWDER CONTENT : 1 +/- 1 mg per Glove
    PROTEIN CONTENT: 80 +/- 20 ppm
    MOISTURE CONTENT: 0.8 % max
    BIOCOMPATABILITY: Biologically Compatible

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

Not Found

Predicate Device(s)

Class I Surgeon's Glove ( Powder free) 79KGO

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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).

0

NOV 2 3 1999

K993349

PAGE NO : 75

1. 510K SUMMARY as required by: 807.92( c )

1.0 APPLICANT

NAME

PH.NO. FAX NO

ADDRESS

SRI.ANUSHAM RUBBER INDUSTRIES .. PVT.LTD. PIONEER MANIKANDAN BUILDINGS, VADASERY NAGAR COIL, TAMIL NADU, INDIA - 629001. : 91-4652-33091,32506. : 91-4652-32871

CONTACT PERSON

: N. PARAMASIVAN : MANAGING DIRECTOR

  1. DEVICE TRADE NAME : NIL

COMMON NAME .. Surgeon's Glove

: Powder free Surgcon's Glovc Classification Namc

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

Class I Powder free Surgical Glove 79KGO that meets all 'the requirements of ASTM D3577.

6.0 Intended use of the Device:

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

Image /page/0/Picture/18 description: The image shows a circular stamp with text around the perimeter. The text reads "SRI ANUSIAM RUBBER" along the top curve and "NAGERCO" along the bottom. There is a star symbol on the left side of the stamp.

1

PAGE NO : 76

| Measured Parameters of Latex
Surgeon's gloves (Powder free)
manufactured by Sri.Anusham Rubber
industries Pvt. Ltd | | ASTM D3577
Requirement for
Latex Surgeon's glove
(Powder free) | |
|-----------------------------------------------------------------------------------------------------------------------------|------|-------------------------------------------------------------------------|----------------|
| Characteristics | SIZE | Value | |
| 1. Length | 5 ½ | 270-272 mm | 245 mm minimum |
| | 6 | 270 - 272 mm | 265 mm minimum |
| | 6 ½ | 270 - 272 mm | 265 mm minimum |
| | 7 | 270 – 272 mm | 265 mm 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 +/- 6mm |
| | 6 ½ | 79mm | 83 +/- 6 mm |
| | 7 | 87mm | 99 +/- 6 mm |
| | 7 ½ | 92mm | 95 +/- 6 mm |
| | 8 | 103mm | 105 +/- 6 mm |
| | 8 ½ | 106mm | 108 +/- 6 mm |
| | 9 | 112mm | 114 +/- 6 mm |

7.0 Technological characteristics of the device compared to predicate device.

    1. Thickness at cuff , Palm and finger tip of all the size is 0 .12, 0 .16 and 0.19mm.
      ASTM D3577 requirement for thickness at cuff, palm and finger tip is 0.1 mm minimum.

PHYSICAL PROPERTIES:

CharacteristicsBEFORE AGEINGAFTER AGEING
SARI ValueASTM
D3577
RequirementSARI ValueASTM
D3577
Requirement
Tensile Strength27 mpa24 mpa20 mpa18 mpa min
Elongation at break %850%750%750%560% min
Modulus at 500 %
elongation.3 mpa5.5 mpa
(max)--

SARI : SRI. ANUSHAM RUBBER INDUSTRIES

Image /page/1/Picture/8 description: The image shows a partial view of a circular stamp or seal. The text "SRI ANUSHA M RI" is visible along the curved edge of the stamp. The text appears to be slightly faded or worn, giving the stamp a vintage or used appearance. The stamp is black and white.

2

PERFORMANCE REQUIREMENT:

PAGE NO : 77

CharacteristicsRelated defectsLevel followed ByLevel As per ASTM D 3577AQL followedAQL as per D3577.
SARI
SterilityFails sterilityAs per IP*As per USP*.NANA
Freedom from HolesHolesS4S41.51.5
DimensionWidth,
Length
Thickness.S2S244
Physical PropertyTensile strength,
Elongation at break before
and after ageingS2S244

IP – INDIAN PHARMACOPEA

POWDER CONTENT

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Image /page/2/Picture/12 description: The image shows a circular stamp with text around the perimeter. The text reads "SRI PRABHATHAM RUBBER INDUSTRIES PVT. LTD." The center of the stamp contains the text "NAGERCOIL".

3

8.0. Performance Data:

The performance test data of the powder free surgical gloves manufactured by Stri. Anusham Rubber Industries Pvt. Ltd is given below.

Measured Parameters of Latex
Surgeon's gloves (Powder free)
manufactured by Anusham Rubber
Industries Pvt.Ltd.,
CharacteristicsSIZEValue
1. Length5 ½270-272 mm
6270-272 mm
6 ½270-272 mm
7270-272 mm
7 ½270-272 mm
8270-272 mm
8 ½270-272 mm
9270-272 mm
2. Width5 ½68 mm
673 mm
6 ½79 mm
787 mm
7 ½92 mm
8103 mm
8 ½106 mm
9112 mm
    1. Thickness at cuff , Palm and finger tip of all the size is 0 .12, 0.16 and 0.19 mm.
      PHYSICAI. PROPERTIFS:
CharacteristicsBefore AgeingAfter Ageing
Tensile Strength27 mpa20 mpa
Elongation at break %850%750%
Modulus at 500 %
elongation.3 mpa-

Image /page/3/Picture/7 description: The image shows a circular stamp with text around the perimeter. The text reads "SRI ANUSHTAN I BBER INDUSTRIES PVT. LTD." with a star symbol. In the center of the stamp, the text "NAGERCOIL" is vertically oriented.

4

PAGE NO : 79

PERFORMANCE REQUIREMENT:

CharacteristicsRelated defectsLEVELAQL
SterilityFails sterilityAs per Indian
Pharmacopea
Freedom from
HolesHolesS41.5
DimensionWidth , Length
Thickness.S24
Physical
PropertyTensile
strength ,
Elongation at
break before
and after
ageing.S24

POWDER CONTENT : 1 + /- 1 mg per Glove

PROTEIN CONTENT: 80 +/- 20 ppm

MOISTURE CONTENT: 0.8 % max

BIOCOMPATABILITY: Biologically Compatible

  1. Clinical Data NA ・・

  2. CONCLUSION OF PERFORMANCE TEST DATA:

The Powder free Surgeon's gloves manufactured by Sri.Anusham Rubber Industries Pvt Ltd

  • -Meet or exceed the ASTM D3577
  • Meet FDA Pin hole Requirement. .
  • Meet labeling claim as shown by the data in 6 -
  1. 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 text around the perimeter and in the center. The text around the perimeter reads "SRI ANUSHAM RUBBER INDUS TRES PVT LTD" with a star on either side of the "D". In the center of the stamp, the text "NAGERCOIL" is printed vertically.

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines that suggest the shape of a bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 3 1999

Mr. N. Paramasivan Managing Director SRI Anusham Rubber Industries Private, Limited Pioneer Manikandan Buildings Vadasery, Naqercoil-629001 Tamil Nadu, S. India

Re : K993349 Trade Name: Surgeon's Glove - Powder Free Regulatory Class: I Product Code: KGO September 28, 1999 Dated: Received: October 5, 1999

Dear Mr. Paramasivan:

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 Regulations, 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

6

Page 2 - Mr. Paramasivan

this response to your the Federal Register. Please note: 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 labeling requlation (21 CFR Part 801 and additionally 809.10 for in yitro 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 qeneral 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,

Timothy A. Ulatowski

thy A. Ulatows Diredtor 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: SRI. ANUSHAM RUBBER INDUSTRIES PVT.LTD.
510(K) No.: K99 3349
DEVICE NAME: POWDER FREE SURGEON'S GLOVE

INDICATIONS FOR USE:Powder free Surgeon's glove is a sterile powder free medical device intended to be worn by operating room personnel to protect a surgical wound from contamination. r

Image /page/7/Picture/4 description: The image is a circular stamp with text around the perimeter and in the center. The text around the perimeter reads "SRI ANUSHAM RUBBER INDUSTRIES PVT. LTD." with a star symbol. The text in the center reads "NAGERCOIL" in a rotated orientation.

OTC

J. Alitsted

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