(15 days)
Not Found
Not Found
No
The device description and intended use clearly define a physical examination glove, with no mention of software, data processing, or AI/ML technologies.
No
The device, a patient examination glove, is intended to prevent contamination between the patient and the examiner, not to treat or alleviate a disease or condition.
No
Explanation: The device is described as an examination glove intended to prevent contamination, not to diagnose a medical condition.
No
The device described is a physical examination glove, which is a hardware medical device, 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 "patient examination glove... worn on the examiner's hand or finger to prevent contamination between the patient and the examiner." This describes a barrier device used for physical protection and hygiene during patient examination.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Lack of Diagnostic Function: The description of the glove and its intended use does not involve any testing of biological samples or providing diagnostic information. It's a physical barrier.
Therefore, the Lano-E Powder-Free Nitrile Examination Glove is a medical device, but it falls under a different category than IVDs.
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
LZA
Device Description
Trade Name: Lano-E Powder-Free Nitrile Examination Glove Common Name: Examination Gloves Classification Name: Patient Examination Glove (per 21 CFR 880.6251) Class I Powder-Free Nitrile examination glove 80LZA that meets a all of the requirements of ASTM Standard D 6319 - 00 Rev A
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
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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)
The Lano-E Powder-Free Nitrile Examination Glove meets the physical property requirements of ASTM D 6319-00 Rev A and the FDA 1000 ml water test both before and after aging.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Powder Residue: Maximum 2mg/glove
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: | 0.10 to 0.15 mm (at center of palm) |
| Finger Thickness: | 0.10 to 0.17 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: | 14.0 Mpa minimum |
| Ultimate Elongation: | 700% minimum |
| Pinhole AQL | 1.5 minimum |
| AFTER AGING | |
| 14.0 Mpa minimum | |
| 500% minimum | |
| 1.5 minimum |
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
2005 APR 8 -
510(k) Number: K050765
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
Device Listing No. B 034622 Registration No. 8040880 K050765 510(k) Number:
Official Correspondent in the United States:
Kenneth J. Stanton, President UG Healthcare (USA) Inc. 2420 Carson St., Suite 125 Torrance, CA 90501
Telephone No .: (310) 328-7981 Fax No.: (310) 328-7829
Submitted: March 15, 2005
A. Description of the Device Trade Name: Lano-E Powder-Free Nitrile Examination Glove Common Name: Examination Gloves Classification Name: Patient Examination Glove (per 21 CFR 880.6251) Class I Powder-Free Nitrile examination glove 80LZA that meets a all of the requirements of ASTM Standard D 6319 - 00 Rev A
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.
SUMMARY PREMARKET 510(k) NOTIFICATION For Lano-E Powder-Free Nitrile Examination Gloves K050765 510(k) Number: March 23, 2005
1
Summary of Technological Characteristics:
Powder Residue: Maximum 2mg/glove Material: Nitrile Cuff: Beaded Cuff: Quality Assurance: In compliance with ASTM D6319-00 Rev A, EN 455-3 : 2000, EN 455-2 : 2000, EN 455-1 : 2000, ISO 2859-1:1999 and manufactured under ISO9001:2000
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: | 0.10 to 0.15 mm (at center of palm) |
| Finger Thickness: | 0.10 to 0.17 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
| Tensile Strength: | 14.0. Mpa minimum |
|---|---|
| Ultimate Elongation: | 700% minimum |
| Pinhole AQL | 1.5 minimum |
14.0 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
Sizes: XXS - XL
Conclusion: The Lano-E Powder-Free Nitrile Examination Glove meets the physical property requirements of ASTM D 6319-00 Rev A and the FDA 1000 ml water test both before and after aging.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines representing the wings and a wavy line representing the body.
Public Health Service
2005 APR 8
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
N.S. Uni-Gloves Sdn. Bhd. C/O Mr. Kenneth J. Stanton President UG Healthcare (USA) Incorporated 2420 Carson Street Suite 125 Torrance, California 90501
Re: K050765
Trade/Device Name: Lano-E, Powder Free, Nitrile Examination Gloves Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: April 4, 2005 Received: April 5, 2005
Dear Mr. Stanton:
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 Amendments, 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 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Mr. Stanton
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), please contact the Office of Compliance at (240) 276-0115 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.
Sincerely yours,
Quls
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
Page - 5
510(k) Number (if known): __K050765
Device Name: Lano-E, Powder Free, Nitrile Examination Gloves
Indications For Use The Lano-E, Powder Free, Nitrile Examination Gloves is a disposable r the Land-E, I owder Froo, Nittio see that is worn on the examiner's hand to prevent contamination between patient and examiner
Prescription Use (Part 21 CFR 801 Subpart D)
: :
.
. "
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shiela A. Murphy, MD 4/8/05
insion Sion-Off) Asion of Anesthesiology, General Hospital, Intection Control. Dental Devices
| Labels | Values |
|---|---|
| Number | 1650/15 |
1