(48 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirement of ASTM Standard D5250-06.
Based on the provided text, the device in question is Tangshan Pufa Plastic Products Co., Ltd. Synthetic Vinyl Patient Examination Gloves - Powder Free. This is a Class I medical device, and the submission is a 510(k) for substantial equivalence to a predicate device, not for the approval of a novel AI/ML-driven diagnostic or therapeutic device. Therefore, many of the requested categories (like "effect size of how much human readers improve with AI vs without AI assistance" or "sample size for the training set") are not applicable to this type of device and study.
Here's the information that is applicable based on the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard / Test) | Reported Device Performance |
|---|---|
| ASTM-D-5250-06 (Physical and Dimensions Testing) | Meets all requirements for Physical and Dimensions Testing, Inspection Level S-2, AOL 2.5. |
| FDA 1000 ml. Water Fill Test (Pinhole) | Meets requirements with samplings of AOL 2.5, Inspection Level 1. |
| Primary Skin Irritation | No primary skin irritant reactions. |
| Skin Sensitization (Allergic Contact Dermatitis) | No sensitization reactions. |
| Powder Content (for Powder-Free claim) | Meets "powder-free" claim (contains no more than 2 mg powder per glove). |
| Biocompatibility requirements | Meets requirements (as shown by data in Section 7). |
| Applicable 21 CFR references | Conforms fully to applicable 21 CFR references. |
| Labeling Claims | Meets labeling claims. |
Study Details
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a single number. The document mentions "samplings of AOL 2.5, Inspection Level 1" for the FDA Water Fill Test, and "Inspection Level S-2, AOL 2.5" for Physical and Dimensions Testing. These are statistical sampling plans based on Acceptable Quality Limits (AQLs) but do not provide a total sample count.
- Data Provenance: Not explicitly stated beyond the manufacturer being in China. The testing was conducted to meet ASTM and FDA standards. The nature of the tests on physical properties of gloves means the "provenance" is largely the manufacturing process and materials.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The ground truth for glove performance is established by objective physical and chemical testing against defined standards (ASTM, FDA water fill test, biocompatibility). It does not involve expert consensus in the way a diagnostic image interpretation would.
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Adjudication method for the test set: Not applicable. Performance is determined by objective measurements against established standards, not by human adjudication of qualitative data.
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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 a medical device for physical protection, not an AI-driven diagnostic or therapeutic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithmic device.
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The type of ground truth used:
- Objective measurements against established industry standards (ASTM-D-5250-06).
- Regulatory requirements (FDA 1000 ml. Water Fill Test).
- Biocompatibility testing (Primary Skin Irritation, Skin Sensitization).
- Chemical analysis (powder content).
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The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set. The "training" for glove manufacturing involves process control and quality assurance, not data-driven model training.
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How the ground truth for the training set was established: Not applicable. See point 7.
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DEC 22 2009
510 (K) SUMMARY
This summary of 510(K) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21CFR 807.92.
1. Submitter's Identification:
Tangshan Pufa Plastic Products Co., Ltd. Pachigang, Luannan County, Tangshan, Hebei, China Zip Code: 063502
Date summary prepared: October 30, 2009
2. Name of the Device:
Tangshan Pufa Plastic Products Co., Ltd. Synthetic Vinyl Patient Examination Gloves - Powder Free
3. Predicate Device Informaton:
Tangshan Pufa Plastic Products Co., Ltd. Synthetic Vinyl Patient Examination Gloves - Powder Free (K992821)
4. Device Description:
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirement of ASTM Standard D5250-06.
5. Intended Use:
A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
Comparison to Predicate Devices: 6.
Tangshan Pufa Plastic Products Co., Ltd. Synthetic Vinyl Patient Examination Gloves, Powder-Free are substantially equivalent in safety and effectiveness to the Shijiazhuang Hongxiang Plastic Products Co., Ltd. and Sunmax Enterprise Shanghai Co., Ltd. Powder-Free Vinyl Patient Examination Gloves, Powderfree.
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7. Discussion of Non-Clinical tests performed for Determination of Substantial Equivalence are as follows:
The standards used for Tangshan Pufa Plastic Products Co., Ltd.,glove production are based on ASTM-D-5250-06. All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection Level S-2, AOL 2.5.
The FDA 1000 ml. Water Fill Test was also conducted with samplings of AOL 2.5, Inspection Level 1, 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.
There are no special labeling claims and we do not claim our gloves as hypoallergenic is conducted to insure that our gloves meet our "powder-free" claims (contain no more than 2 mg powder per glove).
8. Discussion of Clinical Tests Performed:
Not Applicable -- There is no hypoallergenic claim.
9. Conclusions:
ﺗﺮ
Tangshan Pufa Plastic Products Co., Ltd. Synthetic Vinyl Patient Examination Gloves, Powder-Free conform fully to ASTM-D-5250-06 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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Public Health Service
DEC 22 2009
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Tangshan Pufa Plastic Products Company, Limited C/O Mr. John Zhao Basic Medical Industries, Incorporated 12390 East End Avenue Chino, California 91710
Re: K093439
Trade/Device Name: Patient Vinyl Examination Gloves, Powder free, Non-Sterile,
Non Colored Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: December 7, 2009 Received: December 8, 2009
Dear Mr. Zhao:
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.
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. Zhao
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.goy/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 Tunney
Notary Public, State of S.C.
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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Tangshan Pufa Plastic Products Co., Ltd.
Pachigang, Luannan County, Tangshan City Hebei, China Phone: 315-4167275
INDICATIONS FOR USE
Tangshan Pufa Plastic Products Co., Ltd. Applicant:
510(k) Number: K © 9 343 9
Device Name:
Patient Vinyl Examination Gloves, Powder free, Non-Sterile, Non Colored
Indications of Use:
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)
Prescription Use _____________________________________________________________________________________________________________________________________________________________
Over the Counter Use _________________________________________________________________________________________________________________________________________________________
Factory Initials
Elinot D. Clavine-Will
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
KO 93439 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.