(78 days)
Not Found
Not Found
No
The summary describes a standard medical glove and contains no mention of AI, ML, or related concepts.
No.
The device (a medical glove) is intended to prevent contamination between healthcare personnel and patients, which is a protective rather than a therapeutic function.
No
The device is a medical glove, intended to prevent contamination between healthcare personnel and patients. It does not perform any diagnostic function such as identifying, confirming, or monitoring medical conditions.
No
The device description clearly states it is a physical glove made of nitrile, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use of this device is to be worn on the hand to prevent contamination. It does not involve the analysis of any biological samples.
- The description clearly states it's a medical glove. Medical gloves are classified as medical devices, but not specifically as IVDs.
The information provided aligns with the description of a standard medical glove used for barrier protection, not for diagnostic testing.
N/A
Intended Use / Indications for Use
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient. It is a single use disposable glove.
Product codes
LZA
Device Description
Nitrile Powder Free Patient Examination Gloves (BLUE), Non-sterile
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
Indicated Patient Age Range
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Intended User / Care Setting
healthcare and similar personnel
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.)
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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.
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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.
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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).
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§ 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
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human figures, represented by curved lines, facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
And II DUA
Mr. S. Segaran Managing Director Seltom Pacific SDN. BHD. Lot 25 Jalan PJS 7/17 Sunway Industrial Park 46150 Petaling Jaya, Selangor, Malaysia
RE: K991779 Trade Name: Nitrile Examination Gloves Powder Free (Blue) Requlatory Class: I Product Code: LZA Dated: June 28, 1999 Received: July 02, 1999
Dear Mr. Segaran:
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 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. A 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 the Federal Register. this response to your premarket notification Please note: 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 regulations.
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Page 2 - Mr. Segaran
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 xitro 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 Other general information on your responsibilities CFR 807.97). 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. Ulstanski
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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SELTOM PACIFIC SDN. BHD.
Image /page/2/Picture/1 description: The image shows the words "SELTOM PACIFIC" stacked on top of each other. The word "SELTOM" is on the top line, and the word "PACIFIC" is on the bottom line. The text is in a bold, sans-serif font. The image is in black and white.
(CO. NO. 256686-M) Lot 25, Jalan PJS 7/17, Sunway Industrial Park, 46150 Petaling Jaya, Selangor, Malaysia.
603-7356010 -5826010 603-7342713 I: seltom@pd.jaring.my
INDICATIONS FOR USE
Applicant SELTOM PACIFIC SDN BHD
510(k) Number K991779
Device Name Nitrile Powder Free Patient Examination Gloves (BLUE), Non-stenie
Indications for Use:-
ﻳﺰ.. ﺴ
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.
It is a single use disposable glove.
Clun S. Lin
(Division Sign-Off) (Division Sign-Only and General Hospital 510(k) Number .