(55 days)
This glove is disposable and intended for surgical purpose that is worn on the surgeon's hand to prevent contamination between patient and surgeon.
Sterile Nitrile Surgical Gloves (Powdered)
The provided text is a 510(k) premarket notification letter from the FDA regarding "Sterile Nitrile Surgical Gloves (Powdered)". This document is a regulatory approval letter and does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.
The letter states that the FDA has reviewed the 510(k) premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. This determination is based on the information provided by the manufacturer in the 510(k) submission, which would have included data to demonstrate substantial equivalence, but the specifics of that data are not present in this letter.
Therefore, I cannot provide the requested information based on the given text.
To answer your questions, I would need access to the full 510(k) submission document or a summary thereof, which would detail the performance data, acceptance criteria, study design, and methodology used to demonstrate the substantial equivalence of the Sterile Nitrile Surgical Gloves.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 6 2001
Mr. Foo Khon Pu Managing Director Smart Glove Corporation Sdn Bhd Lot 6487 Batu 5 3/4 Jalan Kapar Klang Selangor, MALAYSIA
Re: K012479
Trade/Device Name: Sterile Nitrile Surgical Gloves (Powdered) Regulation Number: 878.4460 Regulation Name: Surgical Gloves Regulatory Class: I Product Code: KGO Dated: July 27, 2001 Received: August 2, 2001
Dear Mr. Pu:
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.
Please be advised that FDA's issuance of a substantial equivalence determination does not
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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. or are recess are a vith 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 (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) premarket notification. The FDA finding of substantial equivalence of your device to a premarket notificate 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 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.
Sincerely yours,
Rilalrist
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indication for Use Statement: 3.0
INDICATION FOR USE
| Applicant: | SMART GLOVE CORPORATION SDN. BHD. |
|---|---|
| 510(k) Number: Applied for | K012479 |
| Device Name: | Sterile Nitrile Surgical Gloves (Powdered) |
Indication For Use:
This glove is disposable and intended for surgical purpose that is worn on the surgeon's hand to prevent contamination between patient and surgeon.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office Of Device Evaluation (ODE)
Oline S. him
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number
Prescription Use Per 21 CFR 801.109
Over-The-Counter OR (Optional Format 1-2-96)
§ 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).