(354 days)
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.
Non-Sterile, Powder-Free, Nitrile Examination Gloves with Lanolin and Vitamin E Coating, Blue
1. Table of acceptance criteria and the reported device performance:
| Characteristics | Acceptance Criteria (Standards) | Device Performance |
|---|---|---|
| Dimensions | ASTM D 6319-10 | Meets |
| Physical Properties | ASTM D 6319-10 | Meets |
| Freedom from Pinholes | ASTM D 6319-10 and ASTM D 5151-06 (1000ml water test both before and after aging) | Meets |
| Powder-Free Residue | ASTM D 6319-10 and ASTM D 6124-06 (Maximum 2mg/glove) | Meets |
| Biocompatibility | Dermal Sensitization (as per ISO 10993-10:2002) | Not a contact skin sensitizer |
| Primary Skin Irritation Test | Not a primary skin irritant |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the specific sample sizes used for each test (e.g., separate sample sizes for physical properties, pinholes, etc.). However, it refers to compliance with ASTM standards, which would dictate the sample sizes and testing methodologies. The data provenance is from Ug Global Resources Sdn Bhd, based in Malaysia, indicating the tests were conducted by the manufacturer for their 510(k) submission. The type of study is retrospective, as it describes tests performed on existing glove samples to demonstrate compliance with standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable to this type of device and study. The "ground truth" for glove performance is established by standardized, objective tests outlined in ASTM and ISO standards, not by expert consensus or interpretation of subjective data.
4. Adjudication method for the test set:
This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in medical imaging or clinical trial settings where there's subjective interpretation by experts. For glove testing, the results are quantitative measurements against predefined thresholds in the standards.
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:
This information is not applicable. This is a submission for a medical device (examination gloves), not an AI algorithm or diagnostic tool. Therefore, MRMC studies and AI assistance are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used:
The ground truth for this device is based on objective measurements and performance criteria defined by international and national standards, specifically:
- ASTM D 6319-10: Standard Specification for Nitrile Examination Gloves for Medical Application
- ASTM D 5151-06: Standard Test Method for Detection of Holes in Medical Gloves
- ASTM D 6124-06: Standard Test Method for Residual Powder on Medical Gloves
- ISO 10993-10:2002: Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization
These standards provide the methodology and acceptable limits for various properties like dimensions, physical properties, freedom from pinholes, powder residue, and biocompatibility.
8. The sample size for the training set:
This information is not applicable. This is not an AI/machine learning study that involves training and test sets. The glove's performance is evaluated against established standards through direct testing.
9. How the ground truth for the training set was established:
This information is not applicable for the reasons stated in point 8.
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SUMMARY
PREMARKET 510(k) NOTIFICATION
Non-Sterile, Powder-Free, Nitrile Examination Gloves with Lanolin and Vitamin E Coating, Blue
K III 718
JUN - 8 2012
Submission Applicant: UG Global Resources Sdn Bhd 1st Floor No. 18 Jalan Dato' Abd Rahman 70000 Seremban Negeri Sembilan Darul Khusus, Malaysia
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
Description of the Device: Non-Sterile, Powder-Free, Nitrile Examination Gloves with Lanolin and Vitamin E Coating, Blue
Trade Name: Lano-E
Common Name: Examination Gloves A.
Classification Name: Patient Examination Glove (per 21 CFR 880.6250)
Class 1: Powder-Free Nitrile examination glove 80LZA that meets all of the requirements of ASTM D6319-10.
Lano-e Nitrile Powder-Free Examination Gloves, Predicative Devices: #K050765.
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.
Page - 9
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SUMMARY
PREMARKET 510(k) NOTIFICATION Non-Sterile, Powder-Free, Nitrile Examination Gloves with Lanolin and Vitamin E Coating, Blue
Summary of Technological Characteristics:
Material: Nitrile Cuff: Beaded Powder Residue: Maximum 2mg/glove
| Characteristics | Standards | Device Performance |
|---|---|---|
| Dimensions | ASTM D 6319-10 | Meets |
| Physical Properties | ASTM D 6319-10 | Meets |
| Freedom from Pinholes | ASTM D 6319-10 | Meets |
| ASTM D 5151-06 | Meets | |
| Powder-Free Residue | ASTM D 6319-10 | Meets |
| ASTM D 6124-06 | Meets | |
| Biocompatibility | Dermal Sensitization(as per ISO 10993-10:2002 | Not a contact skin sensitizer |
| Primary Skin Irritation Test | Not a primary skin irritant |
Special Properties: Lanolin and Vitamin E inner coating
Packaging: 100 pcs per dispenser box, 10 boxes per case, 1.000 gloves per case
Sizes: XS — XL
Conclusion: Non-Sterile, Powder-Free, Nitrile Examination Gloves with Lanolin and Vitamin E Coating, Blue, meets the physical property requirements of ASTM D 6319-10, the FDA 1000ml water test both before and after aging. This product is as safe, as effective, and performs as well or better than the legally marketed 510 #K050765. It has been supported by results of Biocompatibility Tests. Residual . Powder Contents tests, Physical Property Tests and the 1000ml Water Tight Test.
| Summary Preparation Date | June 7, 2012 |
|---|---|
| -------------------------- | -------------- |
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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 its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white and has a simple, clean design. The eagle is facing to the right.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
UG Global Resources SDN BHD c/o Mr. Kenneth Stanton President UG Healthcare (USA), Incorporated 1565 Sunflower Avenue Costa Mesa, California 92626
8 2012
Re: K111718
Trade/Device Name: Non-Sterile, Powder-Free, Nitrile Examination Gloves with Lanolin and Vitamin E Coating, Blue Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: May 23, 2012 Received: May 29, 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 Eederal Register.
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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.
For
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Anthony D. Watson, B.S., M.S., M.S., M.B.A.
Enclosure
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Indications for Use:
510K K111718
Device Name: Non-Sterile, Powder-Free, Nitrile Examination Gloves with Lanolin
ation Courter - Seconder and Vitamin E Coating, Blue and Vitamin E Coating, Blue
lndications for Use – Non-Sterile, Powder-Free, Nitrile Examination Gloves with . Lanolin and Vitamin E Coating, Blue
is a disposable device intended for Medical Purposes that is worn on the exercity of the server with
finger to prevent contamination between patient and examiner finger 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-Williams
(Division Sign-Off) Civision of Anesthesiology, General Hospital · Rection Control, Dental Devices
510(k) Number:
§ 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.