(66 days)
Not Found
Not Found
No
The device is a standard examination glove and the description and performance studies focus on material properties and biocompatibility, with no mention of AI or ML.
No
The device, a latex examination glove, is intended to prevent contamination between healthcare personnel and the patient. It does not provide any therapeutic benefit or treatment to the patient.
No
The device is described as a glove intended to prevent contamination, not to diagnose any medical condition.
No
The device is a physical product (latex examination gloves) and does not involve any software component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the gloves are for preventing contamination between healthcare personnel and the patient by being worn on the hand. This is a barrier function, not a diagnostic function.
- Device Description: The description focuses on the physical properties and standards met by the gloves (ASTM D 3578-95). There is no mention of analyzing samples from the body or providing diagnostic information.
- Performance Studies: The performance studies described relate to the physical integrity and biocompatibility of the gloves (meeting ASTM standards, skin irritation, sensitization). They do not involve any form of diagnostic testing or analysis of biological samples.
IVD devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform that function.
N/A
Intended Use / Indications for Use
HEALTH + AID ® PREMIUM Powder Frec 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.
Product codes (comma separated list FDA assigned to the subject device)
LYY
Device Description
HEALTH + AID ® PREMIUM Powder Free Latex Examination Gloves meet the current specifications listed under the ASTM Specification D 3578 - 95, Standard Specification for Rubber Examination Gloves. They are natural white in colour and are powder free.
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)
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. Final product is negative for the test for presence of starch using the USP iodine test. 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): 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.
Not Found
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.
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:
JUN 2 1 1999
ﺰ ﺗ
510(k) SUMMARY K 99/30S
HEALTH + AID ® PREMIUM POWDER FREF LATEX EXAMINATION GLOVES
| Submitter's Name : | M.R.G. INDUSTRIES SDN. BIID. | |
|---|---|---|
| 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 : | March 31, 1999 | |
| Name of Device : | ||
| Trade Name : | HEALTH + AID ® PREMIUM POWDER FREE | |
| 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 Powder Free | |
| 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 Powder Free | |
| Latex Examination Gloves meet the current | ||
| specifications listed under the ASTM | ||
| Specification D 3578 - 95, Standard Specification | ||
| for Rubber Examination Gloves. They are | ||
| natural white in colour and are powder free. | ||
| Intended Use of the Device: | HEALTH + AID ® PREMIUM Powder Frec | |
| 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. | ||
| These gloves are then further processed into | ||
| powder free gloves using the existing technology, | ||
| i.e. chlorinating and then washing the surfaces of | ||
| the 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. | ||
| Final product is negative for the test for presence | ||
| of starch using the USP iodine test. | ||
| 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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ుండి
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Image /page/2/Picture/1 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 three human profiles facing right, with flowing lines representing hair or movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 1 1999
Mr. Chonq Eng Lim General Manager M.R.G. Industries Sdn. Bhd. PT4004, Kamunting Industrial Estate P.O. Box 9, 34600 Kamunting Taipinq, Perak MALAYSIA
Re : K991305 Health + Aid® Premium Powder Free Latex Trade Name: Examination Gloves With Protein Labeling Claim (50 Micrograms or Less) Regulatory Class: I Product Code: LYY March 31, 1999 Dated: Received: April 16, 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
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Page 2 - Mr. Chong Eng Lim
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.
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
Directør Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
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)
K991305 *
HEALTH + AID® PREMIUM POWDER FREE LATEX Device Name EXAMINATION GLOVE (PROTEIN LABEL CLAIM) 50 MICROGRAMS OR LESS OF TOTAL EXTRACTABLE PROTEIN PER GRAM.
Indications For Use
HEALTH + AID @ PREMIUM Powderfree 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 contanination 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)
Quis S. Lin
(Division Sign-Off Division of Dental, Infection Control, and General Hospit 1: ' O/k) Number
Prescription Use Per 21 CFR 801.109
OR Over-The-Counter