(123 days)
Not Found
Not Found
No
The device description and intended use clearly define a standard examination glove with no mention of AI or ML capabilities.
No
The intended use states that the device is to "prevent contamination between the patient and the examiner," which is a protective function, not a therapeutic one.
No
Explanation: The device is a patient examination glove, described as a disposable device for preventing contamination between patient and examiner. There is no information to suggest it is used for diagnosing a condition or disease.
No
The device is a physical examination glove made of latex, not software.
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 "disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between the patient and the examiner." This describes a physical barrier for protection, not a device used to examine specimens derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of disease or impairment.
- Device Description: The description focuses on the physical properties, material, and quality standards of a glove. There is no mention of reagents, calibrators, controls, or any components typically associated with in vitro diagnostic tests.
- Classification: The device is classified as a "Patient Examination Glove (per 21 CFR 880.6251) Class I Powder-Free Latex examination glove." This classification falls under general hospital and personal use devices, not IVDs.
- Performance Studies: The performance studies described relate to the physical integrity and barrier properties of the glove (water test, physical property requirements), not the analytical or clinical performance of a diagnostic test.
In summary, the device is a medical device used as a physical barrier during patient examination, not a device used to perform diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
A 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 the patient and the examiner.
Product codes
LYY
Device Description
Trade Name: UniGlove Lano-E Powder-Free Latex Examination Glove
Common Name: Examination Gloves
Classification Name: Patient Examination Glove (per 21 CFR 880.6251)
Class I Powder-Free Latex examination glove 80LYY that meets all the of requirements of ASTM Standard D 3578 - 00
Summary of Technological Characteristics:
Material: Latex
Cuff: Beaded
Powder Residue: Maximum 2mg/glove
Quality Assurance: In compliance with ASTM D3578-00, EN 455-2 : 1995, EN 455-1 : 1993, ISO 2859-1:1989 and manufactured under GMP.
Inspection Parameters:
| Criteria | Inspection Level | AQL |
|---|---|---|
| Dimensions | S-2 | 4.0 |
| Physical Properties | S-2 | 4.0 |
| Water Tight Test 1000ml | G-1 | 1.5 |
| Visual Major Defects | G-1 | 1.5 |
| Visual Minor Defects | G-1 | 2.5 |
Physical Properties:
| Dimensions: | |
|---|---|
| Overall Length: | 240 mm minimum |
| Width: | 95 mm minimum (for medium glove) |
| Palm Thickness: | 0.15 to 0.20 mm (at center of palm) |
| Finger Thickness: | 0.17 to 0.25 mm (at 15mm from tip of center finger) |
| Cuff Thickness: | 0.10 to 0.15 mm (at 40mm from the beaded end) |
BEFORE AGING
Tensile Strength: 21. Mpa minimum
Ultimate Elongation: 700% minimum
Pinhole AQL: 1.5 minimum
AFTER AGING
Tensile Strength: 16.0 Mpa minimum
Ultimate Elongation: 500% minimum
Pinhole AQL: 1.5 minimum
Special Properties: Processed with pharmaceutical quality lanolin as the emollient and conditioning agent. Also contains Vitamin E which complies with the current USP, Ph.Eur., DAB and BP monographs.
Packaging: 100 pcs per dispenser box, 10 boxes per case, 1,000 gloves per case
Conclusion: The UniGlove Powder-Free Latex Examination Glove meets the physical property requirements of ASTM D 3578-00 and the FDA 1000 ml water test both before and after aging.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
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
Image /page/0/Picture/0 description: The image shows the logo for "UC Healthcare (USA) Inc.". The logo consists of the letters "UC" stacked on top of each other on the left side of the image. To the right of the letters is the text "Healthcare (USA) Inc."
2420 Carson Street · Suite 125 · Torrance, CA 90501
Local: 310-328-7981 Toll Free: 800-328-7981 Fax: 310-328-7829
JAN 2 2 2002
SUMMARY PREMARKET 510(k) NOTIFICATION For UniGlove Lano-E Powder-Free Latex Examination Gloves 510(k) Number: Kol3163
Submission Applicant:
N.S. Uni-Gloves Sdn. Bhd. Lot 3 & 4/4510 Senawang Industrial Estate, 70450 Seremban, Negeri Sembilan Telephone No. 60-6-677-2751/2 Malaysia Fax No. 60-6-677-2755
Registration No. 8040880 Devise Listing No. B 034616 510(k) Number:
Official Correspondent in the United States:
Robert D. Vander Leek, President UG Healthcare (USA) Inc. 2420 Carson St., Suite 125 Torrance, CA 90501
Telephone No.: (310) 328-7981 (310) 328-7829 Fax No .:
Submitted: September 14, 2001
A. Description of the Device
Trade Name: UniGlove Lano-E Powder-Free Latex Examination Glove Common Name: Examination Gloves Classification Name: Patient Examination Glove (per 21 CFR 880.6251) Class I Powder-Free Latex examination glove 80LYY that meets all the of requirements of ASTM Standard D 3578 - 00
Intended Use of the Device: A 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 the patient and the examiner.
1
SUMMARY PREMARKET 510(k) NOTIFICATION For UniGlove Lano-E Powder-Free Latex Examination Gloves 510(k) Number:
September 14, 2001
Summary of Technological Characteristics:
Material: Latex Cuff: Beaded Powder Residue: Maximum 2mg/glove Quality Assurance: In compliance with ASTM D3578-00, EN 455-2 : 1995, EN 455-1 : 1993, ISO 2859-1:1989 and manufactured under GMP.
Inspection Parameters:
| Criteria | Inspection Level | AQL |
|---|---|---|
| Dimensions | S-2 | 4.0 |
| Physical Properties | S-2 | 4.0 |
| Water Tight Test 1000ml | G-1 | 1.5 |
| Visual Major Defects | G-1 | 1.5 |
| Visual Minor Defects | G-1 | 2.5 |
Physical Properties:
| Dimensions: | |
|---|---|
| Overall Length: | 240 mm minimum |
| Width: | 95 mm minimum (for medium glove) |
| Palm Thickness: | 0.15 to 0.20 mm (at center of palm) |
| Finger Thickness: | 0.17 to 0.25 mm (at 15mm from tip of center finger) |
| Cuff Thickness: | 0.10 to 0.15 mm (at 40mm from the beaded end) |
BEFORE AGING
AFTER AGING
| BEFORE AGING | |
|---|---|
| Tensile Strength: | 21. Mpa minimum |
| Ultimate Elongation: | 700% minimum |
| Pinhole AQL | 1.5 minimum |
16.0 Mpa minimum 500% minimum 1.5 minimum
Special Properties: Processed with pharmaceutical quality lanolin as the emollient and conditioning agent. Also contains Vitamin E which complies with the current USP, Ph.Eur., DAB and BP monographs.
Packaging: 100 pcs per dispenser box, 10 boxes per case, 1,000 gloves per case
Conclusion: The UniGlove Powder-Free Latex Examination Glove meets the physical property requirements of ASTM D 3578-00 and the FDA 1000 ml water test both before and after aging.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 2 2002
N.S. Uni-Gloves Sdn. Bhd. C/O Robert D. Vander Leek UG Healthcare (USA), Incorporated 2420 Carson Street, Suite 125 Torrence, California 90501
Re: K013163
Trade/Device Name: UniGlove Lano-E Powder-Free Latex Examination Gloves with Protein Content Labeling Claim (50 Micrograms or Less) Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: January 8, 2002 Received: January 9, 2002
Dear Mr. Leek:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendie entiments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvisions 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 Mr.), it nay ob days of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Mr. Leek
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
L. Alatort
Timothy latowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Page__________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known):_KO13163
UNIGLOVE LANO-E POWDER-FREE EXAMINATION GLOVES Device Name:_ WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
Indications For Use.
A 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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ OR Prescription Use_ (Per 21 CFR 801.109) (Optional Format 1-2-96)
Chin S. Lin
Civision Sign-Off) vision of Dental, Infection Control, i Ceneral Hospita i; Number