(80 days)
Not Found
Not Found
No
The summary describes a standard surgical glove and contains no mention of AI, ML, or related technologies.
No
The device is a surgical glove, intended to protect a surgical wound from contamination, which is a protective barrier function and not a direct therapeutic action on the body.
No
Explanation: The device is a surgical 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 (surgical gloves made of rubber) and does not mention any software components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. They are used to diagnose diseases, conditions, or determine the state of health.
- This device is a surgical glove. Its intended use is to protect a surgical wound from contamination by being worn by operating room personnel. It does not involve the examination of any biological specimens.
The description clearly indicates a physical barrier device used during surgery, not a diagnostic tool that analyzes samples.
N/A
Intended Use / Indications for Use
A surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Product codes
KGO
Device Description
Sterile Powdered Latex Surgical Gloves with Protein Labeling Claim (
§ 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 shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 6 2001
Mr. Clinton A. Teck Leong Managing Director SSN Glove (M) Sdn Bhd No. 1, Jalan 203, Off Jalan Tandang Petaling, Jala Selangor, MALAYSIA
Re: K012896
Trade/Device Name: Sterile Powdered Latex Surgical Gloves with Protein Labeling Claim ( 200 Micrograms or Less ) Regulation Number: 878.4460 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: KGO Dated: August 23, 2001 Received: August 28, 2001
Dear Mr. Leong:
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 mendments, 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 approvisions 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. Leong
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 moan that I DX mas mace a aves and regulations administered by other Federal agencies. or the Act of ally I outs an the Act's requirements, including, but not limited to: registration r ou must comply with and 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 OF RT rat 007), assimm (QS) regulation (21 CFR Part 820); and if requirents as set form in als quadistion 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 1 mis letter will and w you to organized a finding of substantial equivalence of your device to 310(k) promative noticate 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 If you desire openite and Rart 809.10 for in vitro diagnostic devices), please contact the and additionally 21 Cr (301) 594-4618. Additionally, for questions on the promotion and Office of Confightance are, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket Alloo, predo 1000 R Part 807.97). Other general information on your responsibilities under notification (11 Crice it from the Division of Small Manufacturers, International and the Net may be obtained 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,
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
2
NOV 1 6 2001
INDICATIONS FOR USE
| Applicant | : | SSN Gloves (M) Sdn Bhd |
|---|---|---|
| 510(k) Number | : | K012896 |
| Device Name | : | Sterile Powdered Latex Surgical Gloves with Protein |
| Labeling Claim |