(106 days)
The powder free vinyl patient examination glove, Clear (non-colored) 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. It is sold as non sterile.
Powder free vinyl patient examination gloves, clear (non-colored), non sterile that meets all of the requirements of ASTM standard D 5250-06, except for sterility requirements.
The provided PDF describes the details of a 510(k) submission for "Powder Free Vinyl Patient Examination Gloves". This document is for a medical device (gloves) and not an AI/ML powered device. Therefore, many of the typical AI/ML study components (like sample size for test/training set, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable here.
However, I can extract the acceptance criteria and the study that proves the device meets them as described in the document.
Acceptance Criteria and Reported Device Performance
The device is a "Powder Free Vinyl Patient Examination Glove" and its performance is assessed against recognized consensus standards for patient examination gloves.
| Description | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimension | Meets ASTM D5250-06 | Meets ASTM D5250-06 |
| Physical Property | Meets ASTM D5250-06 | Meets ASTM D5250-06 |
| Free of Pinhole | Meets ASTM D5151-06 (or 21 CFR 800.20 for predicate) | Meets ASTM D5151-06 |
| Residue Powder | Meets ASTM D6124-06 | Meets ASTM D6124-06 |
| Cytotoxicity | Passes ISO 10993-5 | Passes |
| Primary Skin Irritation | Passes ISO 10993-10 | Passes |
| Dermal Sensitization | Passes ISO 10993-10 | Passes |
Study Information (Non-AI/ML Device Specifics):
Since this is for a patient examination glove and not an AI/ML device, the following points typical for AI/ML studies are not relevant or applicable here. The "study" here refers to the physical and biocompatibility testing conducted on the gloves to ensure they meet the established standards.
- Sample size used for the test set and the data provenance: Not applicable in the context of an AI/ML device. The testing involved physical and chemical properties of the glove samples according to the specified ASTM and ISO standards. The document doesn't provide specific sample sizes for these tests, but they are implied to follow the standard testing protocols. Data provenance is implied to be from the manufacturer's testing of their product.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical product like a glove is determined by measurement against physical standards in a laboratory setting, not by expert consensus in a clinical scenario.
- Adjudication method for the test set: Not applicable. Performance is determined by direct measurement against quantitative standards.
- 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 not an AI/ML device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
- The type of ground truth used: For this device, the "ground truth" is defined by established international consensus standards (ASTM and ISO) for physical properties (dimensions, pinholes, physical strength) and biocompatibility (cytotoxicity, skin irritation, sensitization).
- The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
- How the ground truth for the training set was established: Not applicable.
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Section 5: 510(k) Summary:
This summary of 510k safety and effectiveness information is being submitted In accordance with the requirements of 21CFR 807.92
Submitter & Foreign Manufacture Identification
Wuxi Bingfa Gainlite Gloves Co., Ltd Dacheng Industrial Park, Anzhen Town, Xishan District Wuxi, Jiangsu Province, China Tel: 86- 510-88789372 Submitter's FDA Registration Number: N/A
US Agent and Contact Person
Chengyu Shen Manton Business and Technology Services 5 Carey Street Pennington, NJ 08534 Tel: 608-217-9358 Email: cyshen@aol.com
Date of Summary: July 22, 2010
Powder Free Vinyl Patient Examination Gloves Device Name: Powder Free Vinyl Patient Examination Gloves (or other Proprietary Name: clients private labeling) Common Name: Patient examination glove Classification Name: Patient examination glove Device Classification: I 21 CFR 880.6250 Regulation Number: Panel: General Hospital LYZ Product Code:
Predicate Device Information:
- (1) K100699, "Powder Free Vinyl Patient Examination Gloves, Clear(noncolored)", manufactured by "Shijiazhuang Star Plastic Co., Ltd"
Device description:
Powder free vinyl patient examination gloves, clear (non-colored), non sterile that meets all of the requirements of ASTM standard D 5250-06, except for sterility requirements.
Section 5: 510k Summary Section 5 p 1
NOV. 1 6 2010
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Intended Use:
The powder free vinyl patient examination glove, Clear (non-colored) 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. It is sold as non sterile.
Comparison to Predicate Devices
The powder free vinyl patient examination gloves, non sterile are compared with the following Predicate Devices in terms of intended use, design, material, specifications, and performance.
- (1) K100699, "Powder Free Vinyl Patient Examination Gloves, Clear(noncolored)", manufactured by "Shijiazhuang Star Plastic Co., Ltd"
The following table shows similarities and differences of use, design, and material between our device and the predicate devices.
Table 5.1: Comparison of Intended Use, Design, and Material
| Description | Our Device | Predicate Device (K100699) |
|---|---|---|
| Indication forUse | Disposable device intended for medicalpurposes that is worn on the examiner's handor finger to prevent contamination betweenpatient and examiner. | Same |
| Basic Design | Same | |
| Materials | Poly Vinyl Chloride | Same |
| Size | S, M, L, XL | Information unavailable |
| Single Use | Yes | Yes |
| Sterile | Non sterile | Non sterile |
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The following table shows similarities and differences of the performance between our device and the predicate devices. Tests were conducted following the recommended procedures outlined in the respective consensus standards, and results for Powder Free Vinyl Patient Examination Gloves (or other clients private labeling), manufactured by Wuxi Bingfa Gainlife Gloves Co., Ltd met all relevant requirements in the test standards, and are comparable to the predicate device.
| Description | Our Device | Predicate Device (K100699) |
|---|---|---|
| Dimension | Meets ASTM D5250-06 | Meets ASTM D5250-06 |
| Physical Property | Meets ASTM D5250-06 | Meets ASTM D5250-06 |
| Free of Pinhole | Meets ASTM D5151-06 | Meets 21 CFR 800.20 |
| Residue Powder | Meets ASTM D6124-06 | Meets ASTM D6124-06 |
| Cytotoxicity(ISO10993-5) | Passes | N/A |
| Primary SkinIrritation(ISO 10993-10) | Passes | Passes |
| Dermal sensitization(ISO 10993-10) | Passes | Passes |
Table 5.2: Comparison of Physical, Biocompatibility and Performance Testing
More details of non-clinical tests are summarized in Section 18.
A brief discussion of the non-clinical testing data that was submitted, referenced or relied on to demonstrate that the Subject Device is safe and effective, and whose performance meets the requirements of its user-defined acceptance criteria and intended uses: ·
Powder free vinyl patient examination gloves meet requirements per ASTM D5250-06, ASTM D6124-06, ASTM D 5151-06, ISO 10993-5, and ISO 10993-10. It is safe and effective, and it's performance meets the requirements of its pre-defined acceptance criteria and intended uses.
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A brief discussion of the clinical submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalence.
Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.
Substantial Equivalent Conclusions
Based on the comparison of intended use, design, materials, and performance, our vinyl disposable examination gloves powder free are substantial equivalent to its predicate devices.
Section 5: 510k Summary Section 5 p 4
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an abstract image of a bird-like figure.
Food and Drug Administration 10903 New Flampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Wuxi Bingfa Gainlite Gloves Company, Limited C/O Mr. Chebgyu Shen Official Correspondent Manton Business and Technology Services 5 Carey Street Pennington, New Jersey 08534
NOV 1 6 2010
Re: K102171
Trade/Device Name: Powder Free Vinyl Patient Examination Gloves (or other Clients Private Labeling) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: October 7, 2010 Received: October 12, 2010 .
Dear Mr. Shen:
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.
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Page 2- Mr. Shen
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.
Aemad Dood
for
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
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Image /page/6/Picture/0 description: The image shows a sequence of handwritten alphanumeric characters. The sequence starts with the letter 'K', followed by the numbers '102171'. The characters are written in a simple, clear style, and the image appears to be a close-up of the sequence.
Indications for Use Section 4:
NOV 1 6 2010
510(k) Number (if known): N/A
Device Name: Powder Free Vinyl Patient Examination Gloves (or other clients private labeling)
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Indications for Use:
The powder free vinyl patient examination glove, Clear (non-colored) 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. It is sold as non sterile.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
x Over-The-Counter Use __ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
E. Elizabeth S. Lawrie-Will
(Division Sign-Off) Division of Anesthesiology. General Hospital Infection Control, Dental Devices
510(k) Number: _ K 102 17 | __________________________________________________________________________________________________________________________________________________
§ 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.