(24 days)
Not Found
Not Found
No
The 510(k) summary describes a standard medical glove and contains no mention of AI, ML, or any related technologies or performance metrics typically associated with AI/ML devices.
No
The device is a patient examination glove, intended for preventing contamination, not for treating a disease or condition.
No
The device is described as a "patient examination glove" used to prevent contamination between patient and examiner, not to diagnose a medical condition.
No
The device description clearly states it is a "Pre-Powdered Vinyl Non-sterile Examination Glove," which is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to prevent contamination between patient and examiner by being worn on the hand or finger. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: It's a glove, a physical barrier device.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting substances, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This glove does not fit that description.
N/A
Intended Use / Indications for Use
A pre-powdered patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger(s) to prevent contamination between patient and examiner.
Product codes
LYZ
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 finger(s)
Indicated Patient Age Range
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Intended User / Care Setting
examiner / Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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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
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol consisting of three curved lines, which is the department's logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 9 2004
Shandong Perfect Plastic Company Limited C/O Mr. Alan P. Schwartz Official Correspondent MDI Consultants, Incorporated 55 Northern Boulevard, Suite 200 Great Neck, New York 11021
Re: K042213
Trade/Device Name: Pre- Powdered Vinyl Non-Sterile Examination Gloves Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: August 13, 2004 Received: August 16, 2004
Dear Mr. Schwartz:
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 (1 vir device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device ear of router announcements concerning your device in the Federal Register.
1
Page 2 - Mr. Schwartz
Please be advised that FDA's issuance of a substantial equivalence determination does not I lease be advisod that I Dr. o to termination that your device complies with other requirements modi that 1 Dr. I has made statutes and regulations administered by other Federal agencies. of the Act of ally I ederal baracter and sequirements, including, but not limited to: registration 1 od intist comply with and 807); labeling (21 CFR Part 801); good manufacturing practice and instills (21 es rear of the quality systems (QS) regulation (21 CFR Part 820); and if requirences as bet rests nroduct 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) This letter will anow Jourse boga finding of substantial equivalence of your device to a premaired 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), If you dosite specific at Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may overn 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,
CARS
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
2
SHANDONG PERFECT PLASTIC CO., LTD. NO.3 SUNSHINE RD. WULIAN COUNTY, SHANDONG PROVINCE, CHINA
TEL: 86-633-5321442 FAX: 86-633-5321443
EXHIBIT B
INDICATIONS FOR USE
ShanDong Perfect Plastic Products Co., Ltd. Applicant's Name:
Device Name:
Pre-Powdered Vinyl Non-sterile Examination Glove
Indications For Use:
A pre-powdered patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger(s) to prevent contamination between patient and examiner.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _X (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kein Mully
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K042213