(62 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 Hospital and Personal Use Device panel as Class I, 21 CFR 880.6250, Power Free Vinyl Patient Examination Glove, 80 LYZ, and meets all requirements of ASTM standard D-5250-06e1.
The provided text describes the 510(k) summary for the "Hong Di Plastic Products Co., Ltd. Powder Free Vinyl Patient Examination Gloves." This submission is for a Class I medical device (patient examination glove), which is a low-risk device. As such, the information provided focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing and adherence to recognized standards, rather than complex clinical studies involving human readers or extensive ground truth establishment typical of AI/CADe devices.
Here's an analysis of the provided text against your requested criteria:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Set by Standard) | Reported Device Performance (from Hong Di Gloves) |
|---|---|
| Conformance to ASTM D-5250-06e1 (Physical and dimensions testing) | All testing meets requirements for physical and dimensions testing. |
| FDA 1000 ml. Water Fill Test (AQL 2.5, inspection level I) | Test conducted with samplings of AQL 2.5, inspection level I, meeting these requirements (pinhole FDA requirements). |
| Primary Skin Irritation Test | Results show no primary skin irritant reactions. |
| Skin Sensitization Test (allergic contact dermatitis) | Results show no sensitization reactions. |
| Residual Powder Test (ASTM D-6124-06) | Meets "powder-free" claims (contains no more than 2 mg powder per glove). |
| Biocompatibility requirements | Meets biocompatibility requirements (implied by skin irritation/sensitization tests). |
| Labeling Claims | Meets labeling claims (no special claims, not hypoallergenic). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set:
- For ASTM D-5250-06e1 (Physical and dimensions testing): Inspection level S-2, AQL 4.0. (Specific sample number not given, but refers to a standard sampling plan).
- For FDA 1000 ml. Water Fill Test: AQL 2.5, inspection level I. (Specific sample number not given, but refers to a standard sampling plan).
- For Primary Skin Irritation and Skin Sensitization: Not specified.
- For Residual Powder Test: Not specified (but based on ASTM D-6124-06).
- Data Provenance: Not explicitly stated, but the tests were performed by the manufacturer, Hong Di Plastic Products Co., Ltd., which is located in China. The data would be prospective as it's part of the device's validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This device is a patient examination glove, and its performance evaluation relies on objective, standardized physical and chemical tests, not on expert interpretation of medical images or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The tests are objective and quantitative (e.g., measuring dimensions, water fill, powder count, skin reaction), not subject to expert 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
Not applicable. This device is a glove and does not involve AI or human readers for its intended use.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithmic or AI-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by objective measurements and adherence to recognized industry standards (ASTM) and regulatory requirements (FDA). For example:
- Physical properties (tensile strength, elongation, dimensions) are measured against ASTM D-5250-06e1 specifications.
- Pinhole integrity is assessed by the FDA 1000 ml Water Fill Test.
- Biocompatibility is assessed through in-vitro/in-vivo tests for irritation and sensitization.
- Powder content is measured against ASTM D-6124-06.
8. The sample size for the training set
Not applicable. This device does not use machine learning or AI, and therefore does not have a "training set" in that context. The manufacturing process is controlled to meet the specifications.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.
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510(K) SUMMARY
SEP 2 7 2010
ﻣﯿﮟ ﻭﺍﻗﻊ ﮨﮯ۔
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: K102098
l. Owner's Identification:
Mr. Zhiqiang Qiao Hong Di Plastic Products Co., Ltd. Donggao Industrial Zone, Zanhuang, Hebei, CHINA 050000 Date Summary Prepared: June 4, 2010
2. Name of the Device:
Hong Di Plastic Products Co., Ltd. Powder Free Vinyl Patient Examination Gloves
3. Predicate Device Information:
Better Care Plastic Products Co., Ltd Powder Free Vinyl Patient Examination Glove
4. Device Description:
Classified by FDA's General Hospital and Personal Use Device panel as Class I, 21 CFR 880.6250, Power Free Vinyl Patient Examination Glove, 80 LYZ, and meets all requirements of ASTM standard D-5250-06e1.
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.
6. Comparison to Predicate Devices:
Hong Di Plastic Products Co., Ltd.'s Powder Free Vinyl Patient Examination Gloves is substantially equivalent in safety and effectiveness to the Better Care Plastic Products Co., Ltd's Powder Free Vinyl Patient Examination Glove.
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7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as Follows:
The standards used for Hong Di Plastic Products Co., Ltd.'s glove production are based on ASTM D-5250-06e1. 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:
Hong Di Plastic Products Co., Ltd.'s Powder Free Vinyl Patient Examination Gloves conform fully to ASTM D-5250-06e1 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. The device herein mentioned is as safe, as effective, and performs as well as or better than the predicate device.
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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 forming its body and wing. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenuc Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Hong Di Plastic Products Company, Limited C/O Ms. Jie Liu Gloveco, Incorporated 3973 Schaefer Avenue Chino, California 91710
SEP 2 7 2010
Re: K102098
Trade/Device Name: Powder Free Vinyl Patient Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: June 4, 2010 Received: July 27, 2010
Dear Ms. Jie 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/ResourcesforYou/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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Attachment A
INDICATION FOR USE
SEP 27 2010
510 (k) NUMBER (IF KNOW): APPLICANT: DEVICE NAME:
K102098 Hong Di Plastic Products Co., Ltd. Powder Free Vinyl Patient Examination Gloves __ .
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.
Over-The-Counter-Use _ Prescription Use AND/ OR (21CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrent of CDRH, Office of eral Hospital Infection Con trol Dental
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.