(44 days)
Powder Free Vinyl Patient Examination Gloves, Colored (Yellow) 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.
Powder free Vinyl Patient Examination Gloves, Colored (Yellow) that meets all of the requirements of ASTM standard D 5250-06.
Here's an analysis of the acceptance criteria and study information for the K102570 submission, formatted as requested:
Acceptance Criteria and Device Performance Study for K102570
The device in question is "Powder free Vinyl Patient Examination Gloves, Colored (Yellow)." The submission focuses on demonstrating substantial equivalence to a predicate device by meeting established ASTM standards and FDA regulations for patient examination gloves.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimension | ASTM standard D 5250-06 | Meets |
| Physical Properties | ASTM standard D 5250-06 | Meets |
| Freedom from pinholes | 21 CFR 800.20 (Waterleak test on pinhole AQL) | Meets |
| Powder Residual | ASTM standard D 5250-06 and D6124-01 | <2mg/glove |
| Biocompatibility: Primary Skin Irritation | Primary Skin Irritation in rabbits (ISO10993-10) | Passes (Not a Primary Skin Irritation) |
| Biocompatibility: Dermal Sensitization | Dermal sensitization in the guinea pig (ISO10993-10) | Passes (Not a Dermal sensitization) |
Study Information
Based on the provided document, the studies conducted are non-clinical, focusing on laboratory testing rather than clinical trials involving human subjects.
2. Sample Size for Test Set and Data Provenance
The document does not specify the exact sample sizes used for each individual test (e.g., number of gloves tested for dimensions, pinholes, etc.). However, it indicates adherence to established standards (ASTM, ISO, 21 CFR), which typically define appropriate sampling methodologies for such tests.
The data provenance is from Tangshan Kangjie Glove Co., Ltd. (China), and the tests would be considered prospective as they were conducted to demonstrate compliance of the manufactured gloves.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This section is not applicable. The "ground truth" for glove performance is established by technical standards and regulations (ASTM D5250-06, 21 CFR 800.20, ASTM D6124-01, ISO10993-10), not by expert consensus on individual cases. Lab technicians and engineers with expertise in these standards would conduct the tests.
4. Adjudication Method for the Test Set
This section is not applicable. The evaluations are based on objective measurements and pass/fail criteria defined by the cited standards, not on subjective interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices where human readers interpret results, sometimes with AI assistance. For patient examination gloves, the performance evaluation is based on material properties and regulatory compliance, not reader interpretation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This section is not applicable. The device is a physical product (gloves), not an algorithm or AI system. Its performance is inherent in its material and manufacturing, not in an independent computational process.
7. Type of Ground Truth Used
The ground truth used for performance evaluation is based on technical standards and regulatory requirements. Specifically:
- ASTM D5250-06: Standard Specification for Poly(Vinyl Chloride) Patient Examination Gloves. This standard dictates requirements for dimensions, physical properties, and powder residue.
- 21 CFR 800.20: Regulations regarding general requirements for performance standards, specifically related to the waterleak test for freedom from pinholes.
- ASTM D6124-01: Standard Test Method for Residual Powder on Medical Gloves.
- ISO 10993-10: Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization.
8. Sample Size for the Training Set
This section is not applicable. There is no "training set" in the context of evaluating physical properties of patient examination gloves. The manufacturing process is controlled to ensure consistent product quality, but there isn't a machine learning model being trained.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable, as there is no training set for this device.
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510(K) Summary
"This summary of 5 10(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92."
"The assigned 510(k) number is: ______________________________________________________________________________________________________________________________________________
OCT 2 1 2010 .
),
Premarket Notification [510(k)] Summary
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[(a)(1)]. The summary contains on the first page, preferably on your letterhead paper, the submitter's name, address, phone and fax numbers, name of contact person, and date the summary was prepared :
| Submitter's name : | TANGSHAN KANGJIE GLOVE CO., LTD. |
|---|---|
| Submitter's address : | PACHIGANG, LUANNAN COUNTY, TANGSHAN CITY,HEBEI PROVINCE, 063500, CHINA |
| Phone number : | (86) 315-4169201 |
| Fax number : | (86) 315-4169311 |
| Name of contact person: | Mr. Fred Zhang |
| Date the summary was prepared: | Aug. 10th, 2010 |
[(a)(2)]. The name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known
| Device Name: | Powder free Vinyl Patient Examination Gloves, Colored(Yellow) | |
|---|---|---|
| Proprietary/Trade name: | Powder Free Vinyl Patient Examination Gloves | |
| Common Name: | Patient examination glove | |
| Classification Name: | Patient examination glove | |
| Device Classification: | I | |
| Regulation Number: | 21 CFR 880.6250 | |
| Panel: | General Hospital (80) | |
| Product Code: | LYZ |
[(a)(3)]. An identification of the legally marketed device to which your firm is claiming substantial equivalence .
Class I* powder free vinyl patient examination gloves , colored (yellow) that meets all of the requirements of ASTM standard D 5250-06.
Predicate device : Powder free Vinyl Patient Examination Gloves(White, Yellow), SHUIAZHUANG MANFUL LIGHT INDUSTRIAL PRODUCTS CO., LTD. K051156 .
[(a)(4)] A description of the device
Device Description : Powder free Vinyl Patient Examination Gloves, Colored (Yellow) that meets all of the requirements of ASTM standard D 5250-06.
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[(a)(5)] The summary describes the intended use of the device
Device Intended Use: Powder free Vinyl Patient Examination Gloves, Colored (Yellow) 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)(6)] A summary of the technological characteristics of new device compared to the predicate device.
The powder free vinyl patient examination gloves, non sterile are summarized with the following technological characteristics compared to ASTM or equivalent standard.
| Characteristics | Standard | Device performance |
|---|---|---|
| Dimension | ASTM standard D 5250-06 | Meets |
| Physical Properties | ASTM standard D 5250-06 | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-06and D6124-01 | <2mg/glove |
| Biocompatability | Primary Skin Irritation inrabbits | PassesNot a Primary Skin Irritation |
| Dermal sensitization in theguinea pig | PassesNot a Dermal sensitization |
[(b)(1)} A brief discussion of the nonclinical submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalence .
Powder free Vinyl Patient Examination Gloves, Colored (Yellow) meet requirements per ASTM D5250-06, per ASTM D6124-01, per 21 CFR 800.20 and ISO10993-10.
[(b)(2)] 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.
[{b)(3)] The conclusions drawn from the nonclinical and clinical tests that demonstrate that the device is as safe,as effective, and performed as well or better than the legally marketed device identified in (a)(3).
It can be concluded that the Powder Free Vinyl Patient Examination Gloves meet the ASTM standard or equivalent standard and FDA requirements for waterleak test on pinhole AQL., meet labeling claims .
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service .
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Tangshan Kangyuan Glove Company, Limited C/O Mr. Chu Xiaoan Room 1606 Building 1. Jianxing Yuan, #209 Bei Si Huan Beijing China 100083
OCT 2 1 2010
Re: K102570
Trade/Device Name: Powder Free Vinyl Patient Examination Gloves, Colored (Yellow) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: August 10, 2010 Received: September 7, 2010
Dear Mr. Xiaoan:
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. Xiaoan
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/AboutEDA/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.fdagov/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 vours.
Wh 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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INDICATIONS FOR USE
2010
Applicant: TANGSHAN KANGJIE GLOVE CO.,LTD.
510(k) Number (if known): *
Device Name: Powder Free Vinyl Patient Examination Gloves, Colored (Yellow)
Indications For Use:
Powder Free Vinyl Patient Examination Gloves, Colored (Yellow)_ 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.
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), General Hospital
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
510(k) Number: K102570
§ 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.