(24 days)
Not Found
Not Found
No
The device is a latex examination glove, and the description focuses on material properties and performance standards, with no mention of AI or ML.
No
The device is a glove intended to prevent contamination, not to provide therapy.
No
The device, "HEALTH + AID® PREMIUM Pre-powdered Latex Examination Glove," is described as a single-use device worn on the hand to prevent contamination. Its intended use focuses on barrier protection for medical purposes, not on diagnosing any condition or disease.
No
The device description clearly identifies the device as "Pre-powdered Latex Examination Glove," which is a physical, hardware product. There is no mention of software as the primary or sole component.
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 glove worn on the hand to prevent contamination between healthcare personnel and the patient. This is a barrier device for infection control.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens from the human body to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description: The description focuses on the physical properties and standards met by the glove (ASTM D 3578 - 95).
- Performance Studies: The performance studies described relate to the physical integrity and biocompatibility of the glove, not its ability to perform a diagnostic test.
IVD devices are typically used to test samples like blood, urine, tissue, etc., to detect or measure substances or characteristics related to a person's health. This glove does not perform such a function.
N/A
Intended Use / Indications for Use
HEALTH + AID® PREMIUM Pre-powdered Latex Examination Gloves are intended for single use for medical purposes and are worn on the hand of health care and similar personnel to prevent contamination between the health care personnel and the patients.
HEALTH + AID® PREMIUM Pre-powdered Latex 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
LYY
Device Description
HEALTH + AID® PREMIUM Pre-powdered Latex Examination Gloves meet the current specifications listed under the ASTM Specification D 3578 - 95, Standard Specification for Rubber Examination Gloves.
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)
Nonclinical laboratory and animal data indicate that the powder free product meets all performance and biocompatability requirements.
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
3
510(k) SUMMARY
HEALTH + AID® PREMIUM PRE-POWDERED FRÉE LATEX 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 5555 |
| Submitter 's Fax Number : | 605 891 2688 |
| Name of Contact Person : | Goh, See Khek |
| Date of Preparation : | May 23, 1998 |
| Name of Device : | |
| Trade Name : | HEALTH + AID® PREMIUM PRE-POWDERED |
| LATEX EXAMINATION GLOVES | |
| Common Name : | Latex examination gloves |
| Classification Name : | Patient Examination Gloves |
| Legally Marketed Device to Which | |
| Equivalency is Being Claimed : | HEALTH + AID® PREMIUM Pre-powdered |
| Latex Examination Gloves as described in the | |
| 510(k) notification are substantially equivalent to | |
| the Class 1 patient examination glove 80LYY. It | |
| meets all the current specifications listed under | |
| the ASTM Specification D 3578 - 95, Standard | |
| Specification for Rubber Examination Gloves. | |
| Description of the Device : | HEALTH + AID® PREMIUM Pre-powdered |
| Latex Examination Gloves meet the current | |
| specifications listed under the ASTM | |
| Specification D 3578 - 95, Standard Specification | |
| for Rubber Examination Gloves. They are | |
| Intended Use of the Device: | HEALTH + AID® PREMIUM Pre-powdered |
| Latex Examination Gloves are intended for single | |
| use for medical purposes and are worn on the | |
| hand of health care and similar personnel to | |
| prevent contamination between the health care | |
| personnel and the patients. | |
| Summary of Technological | |
| Characteristics Compared to the Predicate | |
| Device : | There are no different technological |
| characteristics. Gloves are made from natural | |
| rubber compound and the initial products are | |
| powdered natural 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 Specification | |
| for Rubber Examination Gloves. | |
| Primary skin irritation testing in the rabbit and | |
| delayed contact sensitization testing in the guinea | |
| pig indicate no irritation or sensitization. | |
| Brief Discussion of Clinical Tests : | No new clinical tests were conducted under this |
| 510(k). | |
| Conclusions Drawn for the Nonclinical | |
| and Clinical Tests : | Nonclinical laboratory and animal data indicate |
| that the powder free product meets all | |
| performance and biocompatability requirements. | |
| Other Information Deemed Necessary by | |
| FDA : | Not applicable |
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Image /page/2/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 image of an eagle or bird-like figure with three curved lines representing its wings or body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 22 1998
Mr. See Khek Goh ·M.R.G. Industries Sdn. Bhd. PT 4004, Kamunting Industrial Estate P.O. Box 9 34600 Taiping Perak MALAYSIA
Re : K981893 Health + Aid® Pre-Powdered Latex Trade Name: Examination Gloves with 100 mcgm or Less Total Water Extractable Protein Regulatory Class: I Product Code: LYY Dated: May 29, 1998 Received: May 29, 1998
Dear Mr. See Khek Goh:
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 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. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
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Page 2 - Mr. See Khek Goh
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA described in your sie in promalence of your device to a legally marketed predicate device results in a classification for your marketed predicate actros 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) 594-4692. 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.fday.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director
Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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Attachment 2
INDICATIONS FOR USE
| Applicant | : | M.R.G. INDUSTRIES SDN. BHD.
PT 4004, Kamunting Industrial Estate
P.O. Box 9
34600 Taiping Perak
MALAYSIA |
|-----------------------------|---|----------------------------------------------------------------------------------------------------------------------|
| 510(k) Number
(if known) | : | K981893 * |
| Device Name | : | HEALTH + AID® PREMIUM PRE-POWDERED LATEX
EXAMINATION GLOVE (PROTEIN LABEL CLAIM) |
| Indications For Use | : | 100mcg/gm or less total water extractable
protein per gram |
| | | HEALTH + AID® PREMIUM Pre-powdered Latex 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)
Chris S.
(Division Sign-Off)
( Division of Dental, Infection Control,
and General Hospital, Infection Control, and General Hospital, Infection -510(k) Number
Over-The-Counter OR
Image /page/4/Picture/10 description: The image shows a simple line drawing. There is a horizontal line across the bottom of the image. Above the line is an "X" shape. The lines of the "X" intersect near the middle of the image.