(64 days)
Not Found
Not Found
No
The description is for a powdered patient examination glove and contains no mention of AI or ML technology.
No
The device is a powdered patient examination glove, intended to be worn on the hand or fingers for hygienic purposes. Its description does not mention any therapeutic indication or function.
No
Explanation: The device is described as a glove intended to be worn on the hand or fingers to facilitate examination and prevent contamination, not to diagnose a medical condition.
No
The device description clearly states it is a physical glove made of natural rubber latex or synthetic material, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states the device is a "powdered patient examination glove" intended to be worn on the hand or fingers for protection.
- Intended Use: The intended use is for "synthell material that bears powder to facilities don't is neemals and other conteminants," which describes a barrier function, not a diagnostic test performed on a biological sample.
The device is a physical barrier product, not a diagnostic tool that analyzes biological samples.
N/A
Intended Use / Indications for Use
A powdered patient examination glove is a disposable device made of natural rubber latex or synthetic material that bears powder to facilitate donning and is intended to be worn on the hand or fingers(s) for medical purposes to provide a barrier against numerous and other contaminants. For Indications for Use.
Product codes
LZA
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
hand or fingers(s)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Shanghai Glovmax Enterprise Company Limited C/O Ms. Susan D. Goldstein-Falk MDI Consultants, Incorporated 55 Northern Boulevard, Suite 200 Great Neck, New York 11021
Re: K021000
Trade/Device Name: Shanghai Glovmax Enterprise Powdered Blue Nitrile Examination Glove Regulation Number: 880.6250 Regulation Name: Examination Glove Regulatory Class: I Product Code: LZA Dated: March 26, 2002 Received: March 28, 2002
MAY 3 1 2002
Dear Ms. Falk:
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.
Image /page/0/Picture/9 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, with flowing lines representing hair or movement.
1
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,
Patricia Ciconetti for
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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SHANGHAI GLOVMAX ENTERPRISE C
Song Jiang Industrial Zone, Che Dun Branch Zone, Rong Chang Rd No#2., Shanghai, C/O : Room B, 11F No.201, Nanking East Rd., Sec 3, Taipei, Taiwan, R.O.O Tel:886-2-25462479 Fax:886-2-25147612
INDICATIONS FOR USE
Applicant: SHANGHAI GLOVMAX ENTERPRISE CO., LTD
510(k) Number (if known):*
Device Name: Shanghai Glovmax Enterprise Powdered Blue Nitrile Examination Glove
Indications For Use: A powdered patient examintaion glove is a disposable device made of natural nubber latex of in for Indications For USE. A powdered patient camming and is intended to be worn on the hand or fingers (s) for synthell material that bears powder to facilities don't is neemals and other conteminants.
Veich. L. Shick
Hsieh | Shi
Shanghai Glovmax Enterprise Co .,Ltd
(Piease refer to Attachment #3)
(Please do not WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Prescription Use _____________________________________________________________________________________________________________________________________________________________
Per 21 CRF 801.109
Qun S. Lim
(Division Sign-Off) Division of Dental, Infection Contr and General Hospital D 510(k) Number -