(122 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.
Here's a summary of the acceptance criteria and the study details for the Hongze Plastic Technology Co., Ltd. Powder Free Nitrile Patient Examination Gloves, Blue, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Characteristic | Acceptance Criteria (Standard) | Reported Device Performance/Findings |
|---|---|---|
| Physical and Dimensions Testing | ASTM D 6319-00a (2005)e1 (Inspection level S-2, AQL 4.0) | All testing meets requirements. |
| Pinhole Detection | FDA 1000 ml. Water Fill Test (AQL 2.5, inspection level I) | Meets requirements. |
| Primary Skin Irritation | No primary skin irritant reactions | No primary skin irritant reactions. |
| Skin Sensitization | No sensitization reactions (allergic contact dermatitis) | No sensitization reactions. |
| Residual Powder | No more than 2 mg powder per glove (ASTM D 6124-06) | Meets "powder-free" claims (contains no more than 2 mg powder per glove). |
| Biocompatibility | Applicable 21 CFR references (implied by no skin irritation/sensitization) | Meets biocompatibility requirements. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each test. However, it references:
- Physical and Dimensions Testing: Inspection level S-2, AQL 4.0.
- Pinhole Detection (FDA 1000 ml. Water Fill Test): AQL 2.5, inspection level I.
The data provenance is not explicitly stated as "country of origin" but the submitting company is "Hongze Plastic Technology Co., Ltd. West District of Shenze Industrial Zone, Fuqian West Road, Shenze County, Shijiazhuang, Hebei, China". The studies are presented as non-clinical tests performed by the manufacturer to demonstrate substantial equivalence, implying they were conducted after the device's creation (retrospective to the submission, but likely prospective tests during manufacturing/quality control).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the device is a patient examination glove and the testing involves objective physical, chemical, and biological performance criteria against established standards, not interpretation by medical experts.
4. Adjudication Method for the Test Set
This is not applicable. The tests are objective measurements against defined standards (e.g., AQL levels for physical properties, specific thresholds for irritancy). There is no "ground truth" established by human interpretation that would require an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically for diagnostic imaging or interpretation devices where human performance with and without AI assistance is evaluated. This is not relevant for a patient examination glove.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This is not applicable. The device is a physical product (a glove), not an algorithm or AI system. The tests performed are inherent to the product's physical and biological properties.
7. Type of Ground Truth Used
The "ground truth" for the performance tests is based on:
- Established ASTM Standards: D 6319-00a (2005)e1 for physical and dimensional properties, and D 6124-06 for residual powder.
- FDA Requirements: Specifically for the 1000 ml Water Fill Test for pinholes.
- Biocompatibility Testing Protocols: To determine if there are primary skin irritant or sensitization reactions.
8. Sample Size for the Training Set
This is not applicable. The device is not a machine learning model; therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set for this device.
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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: K101594
-
- Submitter's Identification:
Mr. Jack Wang
- Submitter's Identification:
Hongze Plastic Technology Co., Ltd. West District of Shenze Industrial Zone, Fuqian West Road, Shenze County, Shijiazhuang, Hebei, China, 050000
DCT 8 2010
Date Summary Prepared: May 25, 2010
-
- Name of the Device:
Hongze Plastic Technology Co., Ltd. Powder Free Nitrile Patient Examination Gloves, Blue
- Name of the Device:
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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K101594
EXHIBIT #1 Page 2 of 2
6. Comparison to Predicate Devices:
Hongze 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 Hongze Plastic Technology Co., Ltd.'s glove production are based on ASTM D 6319-00a (2005)el. 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:
Hongze Plastic Technology Co., Ltd.'s Powder Free Nitrile Patient Examination Gloves, Blue conform fully to ASTM D 6319-00a (2005)e1 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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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 stripes representing the three branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the left side of the eagle.
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
OCT 8 2010
Re: K101594
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: August 16, 2010 Received: August 17, 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 yours.
Mu 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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Attachment A
INDICATION FOR USE
K101594 510 (k) NUMBER (IF KNOW): Hongze Plastic Technology Co., Ltd. APPLICANT: DEVICE NAME: Powder Free Nitrile Patient Examination Gloves, Blue
INDICATIONS FOR USE:
A patient examination glove is disposable non-sterile device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. .
AND/ OR Prescription Use (Part 21 CFR 801 Subpart D)
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: | K101594 |
§ 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.