K Number
K023912
Device Name
POWDER FREE LATEX SURGEON'S GLOVES CONTAINS 50 MEGM OR LESS OF TOTAL WATER EXTRACTABLE PER GRAM
Date Cleared
2003-02-11

(78 days)

Product Code
Regulation Number
878.4460
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A Surgeon's glove is a device made of natural nusber intended to be worn by operating room personnel to protect a surgicul wound from concamination.
Device Description
POWDERFREE LATEX SURGEON'S GLOVES . Cantains 50 megm on less of Total Water per gram protect
More Information

Not Found

None

No
The document describes a standard surgical glove and contains no mention of AI, ML, or related concepts like image processing, training sets, or performance metrics associated with AI/ML algorithms.

No
A surgeon's glove is intended to protect a surgical wound from contamination, not to treat or diagnose a disease or condition.

No
The device is described as a "Surgeon's glove" intended to protect a surgical wound from contamination, which is a protective barrier function, not a diagnostic one.

No

The device description clearly states it is a physical product (gloves) made of natural rubber, not software.

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: The description details the material and powder content of a glove, which is consistent with a physical barrier device.
  • Lack of IVD Characteristics: The document 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

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

N/A

Intended Use / Indications for Use

A Surgeon's glove is a device made of natural nusber intended to be worn by operating room personnel to protect a surgicul wound from concamination.

Product codes

KGO

Device Description

Not Found

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

Not Found

Key Metrics

Not Found

Predicate Device(s)

Not Found

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

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, with a human profile incorporated into the body of the eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 1 2003

Mr. Joseph J. E. Pereira Managing Director Sanrea Healthcare Private Limited Plot No. 14-C, Cochin Special Economic Zone, Kakkanad, Cochin-682037 Kerala. INDIA

Re: K023912

Trade/Device Name: Powder-free Latex Surgeon's Gloves, Contains 50 Micrograms or Less of Total Water Extractable Protein Per Gram Regulation Number: 878.4460 Regulation Name: Surgeon's Gloves Regulatory Class: I Product Code: KGO Dated: January 15, 2003 Received: January 21, 2003

Dear Mr. Pereira:

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 your 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.

1

Page 2 - Mr. Pereira

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 of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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

Sincerely yours.

Susan Runser

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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ENCLOSURE-II

INDICATIONS FOR USE

APPLICANT

SANREA HEALTHCARE PRIVATE LIMITED

510 (k) NO

VC-20-112

DEVICE NAME

POWDERFREE LATEX SURGEON'S GLOVES . Cantains 50 megm on less of Total Water per gram protect

INDICATIONS FOR USE.

:

.

A Surgeon's glove is a device made of natural nusber intended to be worn by operating room personnel to protect a surgicul wound from concamination.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Qùin S. Lin

Division Signsion of Anesthesiology, General Hospital, a Control, Dental De

510(k) Number. K023912

OR

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)