(80 days)
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.
Sterile Powder Free Latex Surgical Gloves with Protein Labeling Claim ( 50 micrograms or less )
I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any studies conducted on the device. The document is an FDA 510(k) clearance letter for "Sterile Powdered Latex Surgical Gloves with Protein Labeling Claim (50 Micrograms or Less)," confirming its substantial equivalence to a predicate device.
The document includes:
- Trade/Device Name: Sterile Powdered Latex Surgical Gloves with Protein Labeling Claim (50 Micrograms or Less)
- Regulation Number/Name: 878.4460 / Patient Examination Gloves
- Regulatory Class: I
- Product Code: KGO
- 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.
It confirms that the device is substantially equivalent to legally marketed predicate devices, but it does not detail performance metrics, study designs, sample sizes, expert qualifications, or ground truth establishment.
Therefore, I cannot provide the requested table and information about the study.
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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: K012880
Trade/Device Name: Sterile Powdered Latex Surgical Gloves with Protein Labeling Claim ( 50 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 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.
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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 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 and additionally 21 CFR Part 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 Part 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
Sincerely yours,
Ky Kilatrick
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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3.0 Indications for Use Statement:
| NOV 1 6 2001 | INDICATIONS FOR USE | |
|---|---|---|
| Applicant | : | SSN Gloves (M) Sdn Bhd |
| 510(k) Number | : | K012880 |
| Device Name | : | Sterile Powder Free Latex Surgical Gloves with ProteinLabeling Claim ( 50 micrograms or less ) |
| Indication For Use | : | A surgeon's glove is a device made of natural or syntheticrubber intended to be worn by operating room personnelto protect a surgical wound from contamination. |
Section 3 - Page 1 of 1
Olen S. Lin
(Division Sign-Off) Covision of Dental, Infection Control, and General Hospital Devices ் : 0(x) Number J 0
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§ 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).