(85 days)
Not Found
No
The summary describes standard latex examination gloves and explicitly states that AI, DNN, or ML are "Not Found".
No
The device, a medical glove, is intended to prevent contamination, not to treat any specific medical condition or disease.
No
Explanation: The device is a medical glove, which is used as a barrier to prevent contamination. Its function is not to diagnose any condition or disease.
No
The device description clearly states it is a physical product (latex examination gloves) and does not mention any software components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The description clearly states the device is a medical glove worn on the hand to prevent contamination. It acts as a barrier.
- Lack of Diagnostic Function: There is no mention of the glove being used to analyze samples or provide diagnostic information.
The intended use and device description align with a Class I or Class II medical device used for barrier protection, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
A medical gloves is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
Product codes
LYY
Device Description
LATEX EXAMINATION GLOVES, POWDERED WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAM OR LESS)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care and similar personnel
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/2 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" around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human profiles facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
OCT 21 1997
Mr. Chua Hooi Koon Alliance Rubber Products Sdn. Bhd. 878, Jalan Bandar Baru, Sungei Kecil, 14300 Nibong Tebal Pulau Pinang Malaysia
K972801 Re : Alliance Rubber, EC-Grip Powdered Latex Trade Name: Examination Gloves With Protein Content Labeling Claim (200 Microgram or less) Regulatory Class: I Product Code: LYY September 20, 1997 Dated: September 26, 1999 ... ....... Received:
Dear Mr. Koon:
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 enclosure) 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 The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note:
1
Page 2 - Mr. Koon
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 emoduct 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 regulation (21 CFR Part 801 and additionally 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" (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
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation ~ Center for Devices and Radiological Health
Enclosure
2
Alliance Rubber Products Sdn.Bhd.
878, Jalan Bandar Baru, Sungei Kecil, 14300 Nibong Tebal, Pulau Pinang, Malaysia. Company No. : 52446-U Fax : (04)-5932262, 3322034 Tel : (04)-5932235, 5937616
Page :1/1 Date : 08-07-97 Our Ref :CHK/080797/5 Your Ref :
ATTACHMENT 2 :
INDICATION FOR USE
Applicant : ALLIANCE RUBBER PRODUCTS SDN. BHD.
K972801 510(k) Number (if known) : K896673-
Device Name : LATEX EXAMINATION GLOVES, POWDERED WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAM OR LESS)
Trade Name : (1) ALLIANCE RUBBER
(2) EC-GRIP
(3) Other clients private labelling
Indication For Use :
A medical gloves is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
Concurrence of CDRH Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Dans and General H 510(k) Number
Prescription Use Per 21 CFR 801.109 OR
Over-The-Counter