(59 days)
A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Polymer Patient Examination Gloves, 80 LZA, and meets all requirements of ASTM standard D 6319-00a (2005)e1.
The provided text describes the regulatory clearance for "Better Care Plastic Technology Co., Ltd. Powder Free Nitrile Patient Examination Gloves, Blue." It outlines the device's characteristics, intended use, and the non-clinical tests performed to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Conformance to ASTM D 6319-00a (2005)e1 | "All testing meets requirements for physical and dimensions testing conducted on gloves." |
| Pinhole FDA requirements (Water Fill Test) | "The FDA 1000 ml. Water Fill Test was also conducted with samplings of AQL 2.5, inspection level I, meeting these requirements." |
| Biocompatibility (Primary Skin Irritation) | "Primary Skin Irritation... testing was conducted with results showing no primary skin irritant reactions." |
| Biocompatibility (Skin Sensitization) | "...Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no...sensitization reactions." |
| "Powder-free" claim (Residual Powder Test) | "A Residual Powder Test that based on ASTM D 6124-06 for powder at finished inspection is conducted to insure that our gloves meet our 'powder-free' claims (contain no more than 2 mg powder per glove)." |
| Labeling | "There are no special labeling claims and we do not claim our gloves as hypoallergenic on our labels." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Pinhole (Water Fill Test): Inspection level I, AQL 2.5. The specific number of samples is not explicitly stated but is implied by the AQL (Acceptable Quality Limit) and inspection level. These are statistical sampling plans.
- Physical and Dimensions Testing: Inspection level S-2, AQL 4.0. Similar to the pinhole test, the exact number isn't given but is derived from the AQL and inspection level.
- Primary Skin Irritation and Skin Sensitization: The sample size for these biological tests is not specified in the document.
- Residual Powder Test: Not explicitly stated but implies testing of "finished inspection" gloves.
- Data Provenance: The manufacturing company, Better Care Plastic Technology Co., Ltd., is located in Hebei Province, China. It is highly likely the testing was conducted in China. The data is presented as results from tests performed on the device during its production or evaluation, implying a prospective testing approach for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of information is not applicable to this device. This document describes the testing of a physical medical device (examination gloves) for performance characteristics (e.g., strength, impermeability, biocompatibility) against established engineering standards (ASTM) and regulatory requirements (FDA). It does not involve human interpretation of data where "ground truth" would be established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as the evaluation involves objective physical and chemical measurements against predefined standards, not subjective expert assessment requiring 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
This is not applicable. The device is an examination glove, not an AI-assisted diagnostic or interpretative system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. The device is an examination glove, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is defined by established regulatory and industry standards:
- ASTM D 6319-00a (2005)e1 for physical and dimensional properties.
- FDA 1000 ml. Water Fill Test for pinhole integrity.
- ASTM D 6124-06 for residual powder.
- Biocompatibility testing against generally accepted methods for primary skin irritation and sensitization.
8. The sample size for the training set
This is not applicable. There is no "training set" as this device is a physical product, not a machine learning model.
9. How the ground truth for the training set was established
This is not applicable for the same reasons as point 8.
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AUG 0.6 2010
EXHIBIT #1 Page 1 of 2
510(K) SUMMARY
This summary of 510(K) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(K) number is:
l . Submitter's Identification: Mr. Guixi Liu Better Care Plastic Technology Co., Ltd. Fuqian Xi Road, West district of Shenze Industrial Base, Shenze County, Hebei Province, China 050000 Date Summary Prepared: May 20, 2010
2. Name of the Device:
Better Care Plastic Technology Co., Ltd. Powder Free Nitrile Patient Examination Gloves, Blue
3. Predicate Device Information:
Hong Xin Rubber Products Co., Ltd Powder Free Nitrile Examination Gloves, Blue (K070861)
4. Device Description:
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Polymer Patient Examination Gloves, 80 LZA, and meets all requirements of ASTM standard D 6319-00a (2005)e1.
5. Intended Use:
A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
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EXHIBIT #1 Page 2 of 2
6. Comparison to Predicate Devices:
Better Care Plastic Technology Co., Ltd.'s Powder Free Nitrile Patient Examination Gloves, Blue is substantially equivalent in safety and effectiveness to the Hong Xin Rubber Products Co., Ltd's Powder Free Nitrile Examination Gloves, Blue.
7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as Follows:
The standards used for Better Care Plastic Technology Co.. Ltd.'s glove production are based on ASTM D 6319-00a (2005)e1. All testing meets requirements for physical and dimensions testing conducted on gloves. Inspection level S-2, AQL 4.0.
The FDA 1000 ml. Water Fill Test was also conducted with samplings of AQL 2.5, inspection level I, meeting these requirements.
Primary Skin Irritation and Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no primary skin irritant or sensitization reactions.
A Residual Powder Test that based on ASTM D 6124-06 for powder at finished inspection is conducted to insure that our gloves meet our "powder-free" claims (contain no more than 2 mg powder per glove).
8. Labeling:
There are no special labeling claims and we do not claim our gloves as hypoallergenic on our labels.
9. Discussion of Clinical Tests Performed:
Not Applicable - There is no hypoallergenic Claim.
10. Conclusions:
Better Care Plastic Technology Co., Ltd.'s Powder Free Nitrile Patient Examination Gloves, Blue conform fully to ASTM D 6319-00a (2005)e i standard as well as applicable 21 CFR references, and meets pinhole FDA requirements, biocompatibility requirements and labeling claims as shown by data in Section 7. There are no safety/efficacy issues or new claims from the "substantial equivalence" products cited.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Better Care Plastic Technology CP., Limited C/O Ms. Jie Liu Surprotect, Incorporated 3973 Schaefer Avenue Chino, California 91710
AUG 0 6 2010
Re: K101595
Trade/Device Name: Powder Free Nitrile Patient Examination Gloves, Blue Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: July 19, 2010 Received: July 21, 2010
Dear Ms. Liu:
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- Ms. Liu
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 vours.
Susan Turner
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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K10/596
AUG 0,6 2010
Attachment A
INDICATION FOR USE
510 (k) NUMBER (IF KNOW):
APPLICANT: DEVICE NAME: Better Care Plastic Technology Co., Ltd. Powder Free Nitrile Patient Examination Gloves, Blue
INDICATIONS FOR USE:
A patient examination glove is disposable device intended for medical purpose 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 __ (21CFR 801Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrent of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:___ |< 10 i 5 95
§ 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.