(83 days)
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Powdered Yellow Synthetic Vinyl Patient Examination Gloves
The provided document is a 510(k) clearance letter from the FDA for "Powdered Yellow Synthetic Vinyl Patient Examination Gloves." It does not contain information about acceptance criteria or a study proving the device meets those criteria.
Instead, the document states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices, meaning it has the same intended use and technological characteristics as a device already on the market, or has different technological characteristics but those characteristics do not raise new questions of safety and effectiveness and are shown to be at least as safe and effective as the predicate device.
Therefore, I cannot answer the request as the necessary information for acceptance criteria and a study proving the device meets them is not present in the provided text.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 9 - 2005
Shijaizhuang Brilliant Ocean Plastic Company Limited C/O Ms. Emmy Tjoeng Marketing Director Shamrock Manufacturing Company 5445 Daniels Street Chino, California 91710
Re: K043478
K043478
Trade/Device Name: Powdered Yellow Synthetic Vinyl Patient Examination Gloves Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYZ Dated: February 4, 2005 Received: February 23, 2005
Dear Ms. Tjoeng:
We have reviewed your Section 510(k) premarket notification of intent to market the device to We have reviewed your Section Fro(t) promaince is substantially equivalent (for the referenced above and nave determined the develly marketed predicate devices marketed in
indications for use stated in the enclosure) to legally marketed predical Device indications for use stated in the checksates to fegally and of the Medical Device interstate commerce prior to May 20, 1770, the situation with the provisions of
Amendments, or to devices that have been reclassified in a preval of a premarket Amendments, of to devices that have been rocasine approval of a prematice the Federal Food, Drug, and Cosmetic Act (716) mar et et the device, subject to the general
approval application (PMA). You may, therefore, market the Aet include approval appreation (r MA). Tou may and controls provisions of the Act include controls provisions of the Act. The general of the stimes, good manufacturing practice, requirements for annual registian misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III
ns affect If your device is classified (see above) into charols. Existing major regulations affecting.
(PMA), it may be subject to such additional Controls. Existing Time 21, Parts (PMA), it may be subject to such additional contributers. Title 21 . Parts 800 to 898. In
your device can be found in the Code of Federal Regulations, Title 21 . Federal your device can be found in the Code of Peacharter, wour device in the Federal Register.
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Page 2 - Ms. Tjoeng
Please be advised that FDA's issuance of a substantial equivalence determination does not
ement Please be advised that FDA's issuance of a subscribes with other requirements
mean that FDA has made a determination that your devices with other requirements mean that FDA has made a deleminations administered by other Federal agencies.
of the Act or any Federal statutes and regulations administer to: registration of the Act or any Federal statutes and reginations authlinited to: registration
You must comply with all the Act step Recep Red Limited to: registration You must comply with all the Act S requirences, including, sod manufacturing practice
and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 807); labelling (21 CFR Party Bor Clark (21 CFR Part 820); and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); requirements as set forth in the quality systems (Sections 531-542 of the Act);
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)
. The success of the same of the same of the mixelesse of your device to a This letter will allow you to begin malicating your activalence of your device to a
premarket notification. The FDA finding of substantial equivalence and thus, new premarket notification. The FDA miding of substantial of a more of the results and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Patt 801), If you desire specific advice for your device of the Sun please note the regulation
please contact the Office of Compliance at (240) 276-0115. please contact the Office of Comphance at (210) =77, =727 Part 807.97). You
entitled, "Misbranding by reference to premarket notification" (21CFR Part 8) entitled, "Misbranding by reference to premail.ities under the Act from the may obtain other general mionhation on your respections in the summer Assistance at its toll-free DIVIsion of Sman Manatar (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Ques
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Applicant: Shijiazhuang Brilliant Ocean Plastic Co.Ltd.
510(k) Number (if known):_K043478
Device Name: Powdered Yellow Synthetic Vinyl Patient Examination Gloves_____________________________________________________________________________________________________
Indications For Use:
A patient examination glove is a disposable device intended for medical purpose that is A patient examiner's hand to prevent contamination between patient and examiner.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
× Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Soujite Michius Omd
a Str. Off na vi Anesthatiblogy, General Hospital, Judon Control, Dental Davices K 043 478 · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · ·
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination 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). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.