(244 days)
Not Found
Not Found
No
The 510(k) summary describes a medical glove and does not mention any AI or ML capabilities.
No
The device is a glove intended to prevent contamination and provide protection from chemicals, not to treat a medical condition or disease.
No
A patient examination glove is used for protection and to prevent contamination, not to diagnose a medical condition or disease.
No
The device is a physical examination glove, which is a hardware medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "patient examination glove" worn on the hand or finger to prevent contamination and provide protection against certain chemicals. This is a physical barrier device used externally on the examiner.
- IVD Definition: In vitro diagnostics (IVDs) are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. They are used outside the body (in vitro) to analyze these samples.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, diagnostic testing, or any function related to providing information about a patient's health based on internal bodily substances.
Therefore, the device described is a medical device, specifically a protective barrier glove, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
A 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. The extra thickness of this glove is suitable for use in an environment of higher risks, such as Paramedics, Emergency Room, etc. This glove may also provide additional protection in other areas where users are handling certain hazardous chemicals such as chemotherapy drugs, as penetration and permeation to these chemicals are prevented.
Product codes
LYY
Device Description
Absogel Powder Free Latex Examination Gloves with Protein Content (50 micrograms or less) and Chemotherapy Drug Protection Claims
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
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Examiner (e.g., Paramedics, Emergency Room)
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
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
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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. The bottom half of the circle contains a stylized image of a bird or other winged creature. The image is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 1 1999
Ms. Phnq Li Kim Director of Operation and Administration AMPri Rubberware Industries Sdn. Bhd. Lot Nos. B5 & B6, Kawasan Perindustrian MIEL Batang Kali Phase II, 44300 Batang Kali, Selangor, MALAYSIA
Re : K990677 Trade Name: Absogel Powder Free Latex Examination Gloves with Tested For Use With Chemotherapy Drugs & Protein Content (50 micrograms or less) Labeling Claims Regulatory Class: I Product Code: LYY August 18, 1999 Dated: Received: Auqust 20, 1999
Dear Ms. Phnq Li Kim:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosurc) to 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). 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 (Premarket Approval), 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 895. ರಿ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in
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Page 2 - Ms. Phnq Li Kim
the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
y A. Ulatowsk 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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of Page 1 1
510(k) Number (if known); K990677
Device Name: Absogel Powder Free Latex Examination Gloves with Protein Content (50 micrograms or less) and Chemotherapy Drug Protection Claims
Indications For Use:
A 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. The extra thickness of this glove is suitable for use in an environment of higher risks, such as Paramedics, Emergency Room, etc.
This glove may also provide additional protection in other areas where users are handling certain hazardous chemicals such as chemotherapy drugs, as penetration and permeation to these chemicals are prevented.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONȚINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
Image /page/2/Picture/13 description: The image contains a handwritten letter 'X' next to the letter 'e'. The 'X' is larger than the 'e' and is positioned to the right of it. The 'X' is formed by two intersecting diagonal lines, and the 'e' is a lowercase letter with a curved shape.
(Optional Format 1-2-96)
Thien S. Lin
(Division Sign-Off Division of Dental, Infe and General Hospi 510(k) Number