(16 days)
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No
The document describes standard examination gloves and makes no mention of AI or ML technology.
No.
The device is a glove intended to prevent contamination, not to treat or diagnose a medical condition.
No
This device is described as a glove intended to prevent contamination between healthcare personnel and patients, not for diagnosing conditions.
No
The device description clearly states it is a physical product (gloves) and the performance studies focus on physical properties and biocompatibility, not software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "single use device intended for medical purposes that is worn on the hand of health care and similar personnel to prevent contamination between the health care personnel and the patient." This describes a barrier device used externally on the body.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This glove does not perform such a function.
- Device Description: The description focuses on the physical properties and standards met for examination gloves.
- Lack of IVD-related information: There is no mention of analyzing biological samples, reagents, or any other components typically associated with IVD devices.
Therefore, this device is a medical device, specifically an examination glove, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
HEALTH + AID ® PREMIUM Pre - Powdered Nitrile Examination Glove is a single use device intended for medical purposes that is worn on the hand of health care and similar personnel to prevent contamination between the health care personnel and the patient.
Product codes (comma separated list FDA assigned to the subject device)
LZA
Device Description
HEALTH + AID ® PREMIUM Pre - Powdered Nitrile Examination Gloves meet the current specifications listed under the ASTM Specification D 3578 -- 95, Standard Specificatio for Rubber Examination Gloves. They are blu or natural white in colour.
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
health care 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)
Nonclinical laboratory and animal data indicat that the pre- powdered nitrile product meets a performance and biocompatability requirements.
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.
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 applicable
§ 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.
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510(k) SUMMARY
MAY 2 8 1929
HEALTH + AID ® PREMIUM PRE - POWDERED NITRILE 1991640 EXAMINATION GLOVES
| Submitter's Name : | M.R.G. INDUSTRIES SDN. BHD. |
|---|---|
| Submitter's Address : | PT 4004, Kamunting Industrial Estate, |
| 34600 Taiping Perak | |
| Malaysia | |
| Submitter's Phone Number | 605 891 1111 |
| Submitter 's Fax Number : | 605 891 1088 |
| Name of Contact Person : | Lim, Chong Eng |
| Date of Preparation : | April 27, 1999 |
| Name of Device : | |
| Trade Name : | HEALTH + AID ® PREMIUM PRE – |
| POWDERED NITRILE EXAMINATION | |
| GLOVES | |
| Common Name | Nitrile examination gloves |
| Classification Name : | Patient Examination Gloves |
| Legally Marketed Device to Which | |
| Equivalency is Being Claimed : | HEALTH + AID ® PREMIUM Pre – Powdered |
| Nitrile Examination Gloves as described in the | |
| 510(k) notification are substantially equivalent to | |
| the Class 1 patient examination glove (Nitrile) | |
| 80LZA, that meets the current draft ASTM | |
| Standard Specification for Nitrile Examination | |
| Gloves for Medical Application. It also meets all | |
| the current specifications listed under the ASTM | |
| Specification D 3578 – 95, Standard Specification | |
| for Rubber Examination Gloves, EXCEPT for | |
| tensile strength and ultimate elongation. | |
| Description of the Device : | HEALTH + AID ® PREMIUM Pre - Powdered |
| Nitrile Examination Gloves meet the current | |
| specifications listed under the ASTM | |
| Specification D 3578 -- 95, Standard Specificatio | |
| for Rubber Examination Gloves. They are blu | |
| or natural white in colour. | |
| Intended Use of the Device: | HEALTH + AID ® PREMIUM Pre - Powdered |
| Nitrile Examination Gloves are intended fo | |
| single use for medical purposes and are worn o | |
| the hand of health care and similar personnel t | |
| prevent contamination between the health car | |
| personnel and the patients. | |
| Summary of Technological | |
| Characteristics Compared to the Predicate | |
| Device : | There are no different technological |
| characteristics. Gloves are made from nitril | |
| rubber compound and the initial products an | |
| powdered nitrile latex examination gloves. | |
| Brief Discussion of Nonclinical Tests : | Testing is performed as per ASTM D 3578-95 |
| and 21 CFR 800.20. Gloves meet all the current | |
| specifications listed under the ASTM | |
| Specification D 3578 - 95, Standard Specificatio | |
| for Nitrile Examination Gloves. | |
| Primary skin irritation testing in the rabbit an | |
| delayed contact sensitization testing in the guinea | |
| pig indicate no irritation or sensitization. | |
| Final product is negative for the test for presenc | |
| of starch using the USP iodine test. | |
| Brief Discussion of Clinical Tests : | No new clinical tests were conducted under thi |
| 510(k). | |
| Conclusions Drawn for the Nonclinical | |
| and Clinical Tests : | Nonclinical laboratory and animal data indicat |
| that the pre- powdered nitrile product meets a | |
| performance and biocompatability requirements. |
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Attachment 15
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| Other Information Deemed Necessary by |
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| FDA : |
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: . ・ . Not applicable
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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 8 1999
Mr. Chonq Eng Lim General Manaqer MRG Industries Sdn. Bhd. PT 4004, Kamunting Industrial Estate P.O. Box 9 34600 Kamunting, Taiping, Perak, MALAYSIA
Re : K991640 Health + Aid® Premium Nitrile Exam Gloves Trade Name: Requlatory Class: I Product Code: LZA Dated: May 5, 1999 Received: May 12, 1999
Dear Mr. Chong Eng Lim:
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 regulations 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Druq 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 Reqister. 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 regulations.
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Page 2 - Mr. Chong Eng Lim
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA findinq 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, unive SULSAN
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE
M.R.G. INDUSTRIES SDN. BHD. Applicant PT 4004, Kamunting Industrial Estate P.O. Box 9 34600 Taiping Perak MALAYSIA
来 Kag1640 510(k) Number : (if known)
HEALTH + AID PREMIUM PRE - POWDERED Device Name : NITRILE EXAMINATION GLOVES
Indications For Use :
· · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · ·
HEALTH + AID ° PREMIUM Pre - Powdered Nitrile Examination Glove is a single use device intended for medical purposes that is worn on the hand of health care and similar personnel to prevent contamination between the health care personnel and the patient.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Clim S. Lin
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number
Prescription Use Per 21 CFR 801.109 OR Over-The-Counter