(69 days)
a disposable device intended for medical purpose that is worn on the examiner's a disposable do not internation belween patient and examiner. Tested for Use with Chemotherapy Drugs.
Powder-Free Latex Examination Gloves with Aloe-and Protein Claim, Tested for Powderfriee Latex Cammation Color Color Color Color Color Color on or less on water Extractable Profess per gram
I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is a 510(k) substantial equivalence determination letter from the FDA for "Powder-Free Latex Examination Gloves Green, Contains 50 Micrograms or Less of Total Water Extractable Protein Per Gram, Tested For Use with Chemotherapy Drugs."
This type of letter primarily indicates that the device is substantially equivalent to a legally marketed predicate device and can be marketed. It refers to general controls and regulations but does not detail specific performance acceptance criteria or study results in the way that would typically be found in a study report or clinical trial summary.
Therefore, I cannot provide:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study details.
- Standalone performance details.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
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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 is circular in shape, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle, with three curved lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 2 2002
Ms. Belle L. Chou General Manager Shen Wei (USA) Incorporated 2845 Whipple Road Union City, California 94587
Re: K013795
Trade/Device Name: Powder-Free Latex Examination Gloves Green, Contains 50 Micrograms or Less of Total Water Extractable Protein Per Gram, Tested For Use with Chemotherapy Drugs Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: November 10, 2001 Received: November 14, 2001
Dear Ms. Chou:
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 - Ms. Chou
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,
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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Anachment Two
INDICATION FOR USE
Shen Wei (USA) Inc. Applicant:
Device Name: Powder-Free Latex Examination Gloves with Aloe-and Protein Claim, Tested for Powderfriee Latex Cammation Color Color Color Color Color Color on or less on water Extractable Profess per gram
Indication For Use:
a disposable device intended for medical purpose that is worn on the examiner's a disposable do not internation belween patient and examiner.
Tested for Use with Chemotherapy Drugs.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Qhin S. Lin
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital F (Jik) Number _
Prescription Use Per 21CFR 801 109 OR
Over-The Counter (Optional Format 1-2-96)
§ 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.