K Number
K012067
Device Name
CLINCARE LATEX SURGEON'S GLOVE
Date Cleared
2001-09-17

(77 days)

Product Code
Regulation Number
878.4460
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This Surgeon's Glove is a device made of natural rubber latex intended to be worn by operating room personnel to protect a surgical wound from contamination
Device Description
CLINCARE Latex Surgical Gloves are class I powdered surgeon's gloves, powdered with absorbable dusting powder, and meet all the requirements of ASTM D 3577.
More Information

Not Found

Not Found

No
The document describes a standard surgical glove and makes no mention of AI or ML technology.

No.
The device, a surgical glove, is intended to protect a surgical wound from contamination by operating room personnel; it does not treat or cure a disease or condition.

No

Explanation: The Surgeon's Glove is intended to protect a surgical wound from contamination, not to detect, diagnose, treat, or prevent a disease or condition. It is a protective barrier, not a diagnostic tool.

No

The device is a physical product (surgical gloves) and does not involve any software component.

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

Here's why:

  • Intended Use: The intended use clearly states the device is a "Surgeon's Glove... intended to be worn by operating room personnel to protect a surgical wound from contamination." This describes a barrier device used during surgery, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
  • Device Description: The description focuses on the physical characteristics and standards met by the glove (latex, powdered, ASTM standards). This aligns with a medical device used externally for protection.
  • Lack of IVD Indicators: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.

Therefore, this device falls under the category of a medical device, specifically a surgical glove, and not an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

This Surgeon's Glove is a device made of natural rubber latex intended to be worn by operating room personnel to protect a surgical wound from contamination

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

KGO

Device Description

CLINCARE Latex Surgical Gloves are class I powdered surgeon's gloves, powdered with absorbable dusting powder, and meet all the requirements of ASTM D 3577.
CLINCARE Latex Surgical Gloves are sterile disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination.

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 non clinical tests are as mentioned immediately above
Clinical data is not needed for medical gloves or for most devices cleared by the 510(k) process.
It is concluded that the CLINCARE Latex Surgical Gloves are as safe, as effective, and perform as well as the glove performance standards referenced above and therefore meet: ASTM listed standards, FDA hole requirements, and labeling claims for the product.

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.

Not Found

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

§ 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

K012067

Page 7 of 7

TTK Healthcare Limited Biomed Division 6 Chathedral Road, Chennai - 600 086

1. 510(k) Summary

  • TTK Healthcare, Ltd. 2. 1-B/2 MIDC Area Chikalthana, Aurangabad Maharashtra, India 431210
    Contact: Ms. Meera Rahatkar Telephone: 91-240-488271 91-240-484863 Fax:

June 25, 2001

Trade Name:CLINCARE Latex Surgical Gloves
Common Name:Surgical Gloves
Classification Name:Surgeon's Glove
  • CLINCARE Latex Surgical Gloves are class I powdered surgeon's gloves, powdered with 4. absorbable dusting powder, and meet all the requirements of ASTM D 3577.
  • న్. CLINCARE Latex Surgical Gloves are class I powdered surgeon's gloves, powdered with absorbable dusting powder, and meet all the requirements of ASTM D 3577.
    1. CLINCARE Latex Surgical Gloves are sterile disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination.
    1. CLINCARE latex Surgical Gloves are summarized with the following technological characteristics compared to ASTM or equivalent standards
CharacteristicsStandard
DimensionsMeets ASTM D 3577-00
Physical PropertiesMeets ASTM D 3577-00, Type I
Freedom From HolesMeets ASTM D 3577-00
Biocompatibility
Primary Skin Irritation in RabbitsPasses
Guinea Pig SensitizationPasses
    1. The performance test data of the non clinical tests are as mentioned immediately above
    1. Clinical data is not needed for medical gloves or for most devices cleared by the 510(k) process.
    1. It is concluded that the CLINCARE Latex Surgical Gloves are as safe, as effective, and perform as well as the glove performance standards referenced above and therefore meet:

ASTM listed standards, FDA hole requirements, and labeling claims for the product.

    1. This summary will include any other information reasonably deemed necessary by the FDA.

1

Image /page/1/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an emblem featuring a stylized image of an eagle or bird with three wing-like shapes, suggesting movement or flight.

SEP 1 7 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

TTK Healthcare Limited C/O Mr. Eli J. Carter Consultant 1219 Little Creek Road Durham, North Carolina 27713

Re: K012067

:

Trade/Device Name: Clincare Latex Surgeon's Glove Regulation Number: 878.4460 Regulation Name: Surgeon's Gloves Regulatory Class: I Product Code: KGO Dated: June 22, 2001 Received: July 2, 2001

Dear Mr. Carter:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 12), it device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements

2

Page 2 - Mr. Carter

of the Act or any Federal statutes and regulations administered by other Federal agencies. or the Flor of ally I outhal the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and iboms (21 es results in the quality systems (QS) regulation (21 CFR Part 820); and if requirences as be ronic product radiation control provisions (section 531-542 of the Act; 21); CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your 510(k) Fills letter will and n yourse of substantial equivalence of your device to a promarketed predicated. - I 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- 4618. 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincere v vours.

St. Patrick

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

3

Page 4 of 7

Indications for Use

Applicant:TTK Healthcare Limited
510(k) Number:Not Known K012067
Device Name:Latex Surgeon's Gloves (POWDERED)
Indications for Use:This Surgeon's Glove is a device made of natural rubber latex intended to be worn by operating room personnel to protect a surgical wound from contamination
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(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of DCRH Office of Device Evaluation (ODE)

Chun S. Lim

(Division Sign-Off) Division of Dental, Infection Control, And General Hospital Devices

or

510(k) Number K012067

Prescription Use Per 21 CFR 801.109

Over -the- Counter __