(83 days)
The Powder-Free Black Examination Glove with Protein Labeling Claim (50 micrograms or less total water extractable protein per gram of glove), is a disposable device intended for Medical Purposes that is worn on the examiners hand to prevent contamination between patient and examiner.
Trade Name: Powder-Free Black Latex Examination Glove With Protein Labeling Claim
Common Name: Examination Gloves
Classification Name: Patient Examination Glove (per 21 CFR 880.6251)
Class 1: Powder-Free Latex examination glove 80LYY that meets all of the requirements of ASTM D3578-05.
Powder Residue: Maximum 2mg/glove
Cuff: Beaded
Material: Latex Material. Latex Quality ASSurancer 11: Com859-1:1999 and manufactured under ISO9001:2000
Overall Length: 240 mm minimum
Width: 95 mm minimum (for medium glove)
Palm Thickness: 0.13 to 0.18mm (at center of palm)
Finger Thickness: 0.15 to 0.20 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: 21.0 Mpa minimum
BEFORE AGING Ultimate Elongation: 700% minimum
BEFORE AGING Pinhole AQL 1.5 minimum
AFTER AGING 16.0 Mpa minimum
AFTER AGING 500% minimum
AFTER AGING 1.5 minimum
Special Properties: Black Colorant
Packaging: 100 pcs per dispenser box, 10 boxes per case, 1,000 gloves per case
Sizes: XXS — XXL
The provided document describes the acceptance criteria and performance of a Powder-Free Black Latex Examination Glove. It does not describe a study involving an AI-powered device or human readers. Therefore, several requested sections, such as those pertaining to AI model performance, human expert involvement, and training/test set details, are not applicable.
Here's the available information presented in the requested format:
1. A table of acceptance criteria and the reported device performance
| Criteria | Acceptance Criteria (Minimum/Maximum) | Reported Device Performance |
|---|---|---|
| Physical Properties | Meets all requirements of ASTM D3578-05 | Meets all requirements of ASTM D3578-05 |
| Powder Residue | Maximum 2 mg/glove | Not explicitly stated, but "Powder-Free" implies meeting this or better. |
| Overall Length | 240 mm minimum | 240 mm minimum |
| Width (for medium glove) | 95 mm minimum | 95 mm minimum |
| Palm Thickness | 0.13 to 0.18 mm (at center of palm) | 0.13 to 0.18 mm (at center of palm) |
| Finger Thickness | 0.15 to 0.20 mm (at 15mm from tip of center finger) | 0.15 to 0.20 mm (at 15mm from tip of center finger) |
| Cuff Thickness | 0.10 to 0.15 mm (at 40mm from the beaded end) | 0.10 to 0.15 mm (at 40mm from the beaded end) |
| Before Aging | ||
| Tensile Strength | 21.0 Mpa minimum | 21.0 Mpa minimum |
| Ultimate Elongation | 700% minimum | 700% minimum |
| Pinhole AQL | 1.5 minimum | 1.5 minimum |
| After Aging | ||
| Tensile Strength | 16.0 Mpa minimum | 16.0 Mpa minimum |
| Ultimate Elongation | 500% minimum | 500% minimum |
| Pinhole AQL | 1.5 minimum | 1.5 minimum |
| Water Tightness | Meets FDA 1000 ml water test (both before and after aging) | Meets FDA 1000 ml water test (both before and after aging) |
| Protein Labeling Claim | <50 ug/g total water extractable protein per gram of glove | <50 ug/g total water extractable protein per gram of glove |
| Inspection Parameters | ||
| Dimensions | AQL 4.0 | Not explicitly reported as "performance," but stated as an inspection AQL. |
| Physical Properties | AQL 4.0 | Not explicitly reported as "performance," but stated as an inspection AQL. |
| Water Tight Test 1000ml | AQL 1.5 | Not explicitly reported as "performance," but stated as an inspection AQL. |
| Visual Major Defects | AQL 1.5 | Not explicitly reported as "performance," but stated as an inspection AQL. |
| Visual Minor Defects | AQL 2.5 | Not explicitly reported as "performance," but stated as an inspection AQL. |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample size used for the specific tests to verify these specifications (e.g., how many gloves were tested for tensile strength or pinholes). It refers to "Inspection Parameters" with AQL (Acceptable Quality Level) values (e.g., G-1 AQL 1.5 for Water Tight Test), which implies a sampling plan based on established quality control standards. However, the exact sample size for the presented performance data is not provided.
Data Provenance: The data is generated from testing of the manufacturer's gloves to demonstrate compliance with ASTM D3578-05 and FDA requirements. It is implied to be prospective testing for regulatory submission. The country of origin of the data is not specified beyond the applicant's US address.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a medical device (examination glove) subject to physical and chemical property testing against established standards, not an AI-powered diagnostic device requiring expert interpretation for ground truth.
4. Adjudication method for the test set
Not applicable. This is a medical device (examination glove) subject to physical and chemical property testing, not an AI-powered diagnostic device requiring expert adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a medical device (examination glove) and not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device (examination glove) and not an AI-powered diagnostic device.
7. The type of ground truth used
The "ground truth" for this device's performance is based on:
- Established industry standards: ASTM D3578-05 for physical properties of latex examination gloves.
- Regulatory requirements: FDA 1000 ml water test.
- Specific claims: Protein labeling claim (<50 ug/g).
- Inspection methods: Specified AQL levels for various quality attributes.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is a physical medical device, not an AI model.
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Submission Applicant/Official Correspondent
Kenneth J. Stanton,President UG Healthcare (USA) Inc. 2420 Carson Street, Suite 125 Torrance, California 90501 USA Tel: (310) 328-7981 Fax: (310) 328-7829
NOV 3 U 2006
Registration No. 2087418 Device Listing No. E408504
510(k) Number:
Submitted: September 7, 2006
A. Description of the Device
Trade Name: Powder-Free Black Latex Examination Glove With Protein Labeling Claim
Common Name: Examination Gloves
Classification Name: Patient Examination Glove (per 21 CFR 880.6251)
Class 1: Powder-Free Latex examination glove 80LYY that meets all of the requirements of ASTM D3578-05.
Predicative Devices: Latex Powder-Free Examination Gloves
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 Powder-Free Black Latex Examination Glove With Protein Labeling Claim 510(k) Number: K 062688
Page - 9
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Summary of Technological Characteristics:
Powder Residue: Maximum 2mg/glove Cuff: Beaded Material: Latex Material. Latex Quality ASSurancer 11: Com859-1:1999 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: | 0.13 to 0.18mm (at center of palm) |
| Finger Thickness: | 0.15 to 0.20 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: | 21.0 Mpa minimum |
|---|---|
| Ultimate Elongation: | 700% minimum |
| Pinhole AQL | 1.5 minimum |
AFTER AGING 16.0 Mpa minimum 500% minimum 1.5 minimum
Special Properties:_Black Colorant
Packaging: 100 pcs per dispenser box, 10 boxes per case, 1,000 gloves per case
Sizes: XXS — XXL
Conclusion: The Powder-Free Black Latex Examination Glove With Profein Labeling Claim meets the physical property requirements of ASTM D 3578-05, the FDA 1000 ml water test both before and after aging, and the Protein Labeling Claim Level at <50ug/g.
Page - 10 SUMMARY PREMARKET 510(k) NOTIFICATION Powder-Free Black Latex Examination Glove With Protein Labeling Claim
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Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle or other bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Kenneth J. Stanton President UG Healthcare (USA), Incorporated 2420 Carson Street, Suite 125 Torrance, California 90501-3163
NOV 3 U 2006
Re: K062688
Trade/Device Name: Powder-Free Black Latex Examination Glove with Protein Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: II Product Code: LYY Dated: November 8, 2006 Received: November 15, 2006
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.
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Page 2 - Mr. Stanton
Please be advised that FDA's issuance of a substantial equivalence determination does not I least that FDA has made a determination that your device complies with other requirements moun mat 1 DT mas may Federal statutes and regulations administered by other Federal agencies. of the Act of any I oucture the Act's requirements, including, but not limited to: registration r out must comply with and are reseling (21 CFR Part 801); good manufacturing practice and and listing (21 OF R Part 067), labelity systems (QS) regulation (21 CFR Part 820); and if requirements as bet form inroduct 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) Fins fetter wifi and in J . The FDA finding of substantial equivalence of your device to a premitser notified on. - The Pice 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), n free 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,
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
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Indications for Use
510(k) Number (if known): K062688
Device Name: Powder-Free Black Latex Examination Glove with Protein
Labeling Claim.
Indications for Use: The Powder-Free Black Examination Glove with Protein Labeling Claim (50 micrograms or less total water extractable protein per gram of glove), is a disposable device intended for Medical Purposes that is worn on the examiners 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)
Shula A. Murphy, MD
ion of Anesthesiology, General Hospital,
..con Control, Dental Devices
Number: K062188
Page 1 of
§ 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.