(252 days)
Non-Sterile, Powder-Free, Nitrile Examination Gloves Blue is a disposable device intended for Medical Purposes that is worn on the examiners hand to prevent contamination between patient and examiner.
Non-Sterile, Powder-Free, Nitrile Examination Gloves Blue. 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 of Technological Characteristics:
Cuff: Beaded
Material: Nitrile
Powder Residue: Maximum 2mg/glove
Quality Assurance: In compliance with ASTM D6319-10, ISO 2859-1, manufactured under ISO9001:2008 and ISO 13485:2003
Physical Properties:
Overall Length: 240 mm minimum
Width: 95 mm minimum (for medium glove)
Thickness: .05 mm minimum
BEFORE AGING: Tensile Strength: 14.0 Mpa minimum, Ultimate Elongation: 500% minimum
AFTER AGING: Tensile Strength: 14.0 Mpa minimum, Ultimate Elongation: 400% minimum
Special Properties: None
Packaging: 150 pcs per dispenser box, 10 boxes per case, 1,500 gloves per case
Sizes: XS — XL
This document describes the acceptance criteria and performance of "Non-Sterile, Powder-Free, Nitrile Examination Gloves Blue" (K112012), not an AI device. Therefore, many of the requested sections related to AI device studies (e.g., sample size for test set, ground truth experts, MRMC studies, standalone performance, training set details) are not applicable.
Here's the available information based on the provided text, adapted to the closest relevant categories:
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Powder Residue | Maximum 2mg/glove | Not explicitly stated, but implies meeting this |
| Quality Assurance | In compliance with ASTM D6319-10, ISO 2859-1, ISO9001:2008, ISO 13485:2003 | Stated as being in compliance |
| Dimensions (Inspection) | AQL 4.0 (S-2 level) | Not explicitly stated as pass/fail, but implies meeting this |
| Physical Properties (Inspection) | AQL 4.0 (S-2 level) | Not explicitly stated as pass/fail, but implies meeting this |
| Water Tight Test (1000ml, Inspection) | AQL 1.5 (G-1 level) | Met both before and after aging |
| Visual Major Defects (Inspection) | AQL 1.5 (G-1 level) | Not explicitly stated as pass/fail, but implies meeting this |
| Visual Minor Defects (Inspection) | AQL 2.5 (G-1 level) | Not explicitly stated as pass/fail, but implies meeting this |
| Overall Length | 240 mm minimum | Not explicitly stated as a measured value, but implies meeting this |
| Width (medium glove) | 95 mm minimum | Not explicitly stated as a measured value, but implies meeting this |
| Thickness | 0.05 mm minimum | Not explicitly stated as a measured value, but implies meeting this |
| BEFORE AGING | ||
| Tensile Strength | 14.0 Mpa minimum | 14.0 Mpa minimum |
| Ultimate Elongation | 500% minimum | 500% minimum |
| AFTER AGING | ||
| Tensile Strength | 14.0 Mpa minimum | 14.0 Mpa minimum |
| Ultimate Elongation | 400% minimum | 400% minimum |
| Protein Labeling Claim Level | <50 ug/g | Met <50 ug/g |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes for each test (e.g., for dimensions, physical properties, water tight test). It refers to "inspection levels" (S-2, G-1) and AQL (Acceptable Quality Limit) values, which are used in statistical sampling plans for quality control, but the specific number of units sampled per lot is not provided.
The data provenance is from physical property tests, 1000ml water tight tests, biocompatibility tests, and residual powder content tests performed on the "Non-Sterile, Powder-Free, Nitrile Examination Gloves Blue". The study is inherently a prospective test of newly manufactured gloves against established standards. The country of origin of the data is not explicitly stated beyond the applicant being UG Healthcare (USA) Inc.
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 (gloves) for which ground truth is established by objective physical and chemical measurements against recognized standards (e.g., ASTM D6319-10, FDA 1000 ml water test). It does not involve expert interpretation or diagnosis.
4. Adjudication method for the test set
Not applicable. Testing is based on objective physical/chemical measurements and statistical sampling plans (AQL) against predefined thresholds, not human adjudication of subjective data.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done
No, this is not an AI device, and therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device (gloves), not an algorithm.
7. The type of ground truth used
The ground truth is based on established industry standards and regulatory requirements, including:
- ASTM D 6319-10 (Standard Specification for Nitrile Examination Gloves for Medical Application)
- ISO 2859-1 (Sampling procedures for inspection by attributes)
- ISO 9001:2008 & ISO 13485:2003 (Quality management systems)
- FDA 1000 ml water test (for watertight integrity)
- Specific minimum/maximum thresholds for physical properties (e.g., tensile strength, elongation, dimensions, powder residue).
8. The sample size for the training set
Not applicable. As this is not an AI/machine learning device, there is no "training set."
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
{0}------------------------------------------------
SUMMARY PREMARKET 510(k) NOTIFICATION Non-Sterile, Powder-Free, Nitrile Examination Gloves Blue
MAR_2 1 2012
Submission Applicant: UG Healthcare (USA) Inc. 1565 Sunflower Avenue Costa Mesa. Ca. 92626
Official Correspondent: Kenneth J. Stanton,President UG Healthcare (USA) Inc. 1565 Sunflower Avnue Costa Mesa, Ca 92626 . Tel: (714)444-2248 Fax: (714)444-2271
Trade Name: Non-Sterile, Description of the Device Non-Sterile, Powder-Free, Nitrile Examination Gloves Blue
- A. Common Name: Examination Gloves Classification Name: Patient Examination Glove (per 21 CFR 880.6251) Class 2: Powder-Free Nitrile examination glove 80LZA that meets all of the requirements of ASTM D6319-10. *Predicative Devices: Nitrile 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.
{1}------------------------------------------------
SUMMARY PREMARKET 510(k) NOTIFICATION Non-Sterile, Powder-Free, Nitrile Examination Glove Blue
Summary of Technological Characteristics:
Cuff: Beaded Material: Nitrile
Powder Residue: Maximum 2mg/glove
Quality Assurance: In compliance with ASTM D6319-10, ISO 2859-1, manufactured under ISO9001:2008 and ISO 13485:2003
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: |
| Width: |
| Thickness: |
240 mm minimum 95 mm minimum (for medium glove) .05 mm minimum
BEFORE AGING
AFTER AGING
Tensile Strength: 14.0. Mpa minimum Ultimate Elongation:500% minimum
14.0 Mpa minimum 400% minimum
Special Properties: None
Packaging: 150 pcs per dispenser box, 10 boxes per case, 1,500 gloves per case
Sizes: XS — XL
Conclusion: Non-Sterile, Powder-Free, Nitrile Examination Gloves Blue meets the physical property requirements of ASTM D 6319-10, the FDA 1000 ml water test both before and after aging, and the Protein Labeling Claim Level at <50ug/g. This product is as safe, as effective, and performs as well or better than the legally marketed 510 #K000689. It has been supported by results of Biocompatibility Tests, Residual Powder Content tests, Physical Property Tests and the 1000ml Water Tight Test.
{2}------------------------------------------------
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
MAR 2 1 2012
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Ken Stanton President UG Healthcare (USA), Incorporated 1565 Sunflower Avenue Costa Mesa, California 92626
Re: K112012
Trade/Device Name: Non-Sterile, Powder-Free Blue, Nitrile Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: February 28, 2012 Received: March 1, 2012
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Anthony
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
510k Submission for: Non-Sterile, Powder-Free, Nitrile Examination Gloves Blue
3.0 Indications for Use:
112012 210K
Device Name: Non-Sterile, Powder-Free, Nitrile Examination Gloves Blue
Indications for Use - Non-Sterile, Powder-Free, Nitrile Examination Gloves Blue 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 (Part 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)
Elizabeth F. Clavine William
Page - 5
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:_K1120/2
§ 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.