(152 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 D5250-00.
The provided text is a 510(k) summary for Zibo Goldenline Plastic Products Co., Ltd. Synthetic Vinyl Patient Examination Gloves - Powder Free. This document pertains to the regulatory submission for a medical device (examination gloves), and thus, the concepts of "acceptance criteria," "study," "training set," "test set," "ground truth," and "experts" as they relate to advanced AI/ML algorithms or diagnostic devices are not directly applicable in the same way.
The document primarily focuses on demonstrating substantial equivalence of the gloves to a predicate device, as required for Class I medical devices. This involves showing that the device meets established industry standards and biocompatibility requirements.
Here's an interpretation of your request based on the provided document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard / Test) | Reported Device Performance |
|---|---|
| Physical and Dimensions Testing (ASTM-D-5250-00) | Meets requirements (Inspection Level S-2, AOL 2.5) |
| FDA 1000 ml. Water Fill Test | Meets requirements (AOL 2.5, Inspection Level I) |
| Primary Skin Irritation Testing | No primary skin irritant reactions |
| Skin Sensitization (Allergic Contact Dermatitis) Testing | No sensitization reactions |
| Powder-Free Claims | Contains no more than 2 mg powder per glove |
| Biocompatibility | Meets requirements (as per Section 7 data) |
| Pinhole requirements | Meets FDA requirements (as per Section 7 data) |
| Labeling Claims | Meets requirements (as per Section 7 data) |
| Applicable 21 CFR references | Conforms fully to applicable 21 CFR references |
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 Testing: The document mentions "samplings of AOL 2.5, Inspection Level I" for the FDA 1000 ml Water Fill Test, and "Inspection Level S-2, AOL 2.5" for Physical and Dimensions Testing. These are Acceptable Quality Level (AQL) standards used in statistical quality control for batch inspection, not a fixed sample size in the traditional sense of a clinical study. The AQL specifies the maximum percentage of defective units considered acceptable in a batch. To determine the exact sample size for a given batch size, one would need to refer to military standard tables (e.g., MIL-STD-105E or ISO 2859-1) for single-sampling plans based on the specified inspection levels and AQLs. The document does not explicitly state the number of gloves sampled.
- Data Provenance: The testing was conducted by Zibo Goldenline Plastic Products Co., Ltd. in Zibo, Shandong, China. The testing would have been prospective, as it was performed on the manufactured gloves to assess their quality against the standards.
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)
This concept is not applicable. For an examination glove, "ground truth" is established by adherence to predefined physical and chemical specifications and performance standards (like ASTM-D-5250-00 and FDA water fill test). The "experts" are the testing personnel and the certifying bodies who verify compliance with these standards, not medical experts establishing a diagnostic ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple human readers interpret data to resolve discrepancies. For physical product testing, results are objective measurements against a standard, not subjective interpretations 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
Not applicable. MRMC studies are relevant for diagnostic or AI-assisted interpretation devices. This document describes a physical medical device (gloves) and does not involve human interpretation or AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the examination gloves is defined by:
- Industry Standards: Adherence to ASTM-D-5250-00 for physical properties and dimensions.
- Regulatory Requirements: Meeting FDA's 1000 ml Water Fill Test for barrier integrity and specific biocompatibility requirements (primary skin irritation, skin sensitization).
- Manufacturer Specifications: Meeting internal "powder-free" claims (≤ 2 mg powder per glove).
These are objective, measurable criteria, not subjective expert consensus or diagnostic outcomes.
8. The sample size for the training set
Not applicable. There is no "training set" in the context of examination glove manufacturing and regulatory submission. Training sets are relevant for machine learning algorithms.
9. How the ground truth for the training set was established
Not applicable. As there's no training set, there's no ground truth for it.
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MAR 1 0 2009
510 (K) SUMMARY
KO83015
This summary of 510(KO safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21CFR 807.92.
1. Submitter's Identification:
Mr. Cong Feng Zhao Zibo Goldenline Plastic Products Co., Ltd. Siji Road, Zhangdian District Zibo, Shandong, China Date summary prepared: October 7, 2008
2. Name of the Device:
Zibo Goldenline Plastic Products Co., Ltd. Synthetic Vinyl Patient Examination Gloves - Powder Free
3. Predicate Device Informaton:
Shijiazhuang Hongxiang Plastic Products 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 D5250-00.
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.
6. Comparison to Predicate Devices:
Zibo Goldenline 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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Discussion of Non-Clinical tests performed for Determination of 7. Substantial Equivalence are as follows:
The standards used for Zibo Goldenline Plastic Products Co., Ltd. glove production are based on ASTM-D-5250-00. 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 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.
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).
Discussion of Clinical Tests Performed: . 8.
Not Applicable - There is no hypoallergenic claim.
9. Conclusions:
Zibo Goldenline Plastic Products Co., Ltd. Synthetic Vinyl Patient Examination Gloves, Powder-Free conform fully to ASTM-D-5250-00 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the symbol.
MAR 1 0 2009
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Zibo Goldenline Plastic Products Company, Limited C/o Mr. John Zhao Basic Medical Industries, Incorporated 12390 East End Avenue Chino, California 91710
K083015 Re:
Trade/Device Name: Patient Vinyl Examination Gloves, Powder-free,
Non-Sterile
Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: February 12, 2009 Received: February 17, 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 such 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Syste Y. Mchane O M.D.
Ginette Y. Michaud, M.D. Acting 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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Zibo Goldenline Plastic Products Co., Ltd. Siji Road, Zhangdian District Zibo, Shandong, China
INDICATIONS FOR USE
Zibo Goldenline Plastic Products Co., Ltd. Applicant:
510(k) Number:
Patient Vinyl Examination Gloves, Powderfree, Non-Sterile Device Name:
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 X
Factory Initials
St. Murphy B
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Devices Division of Anoother of Antal Devices
510(k) Number: KOSC
§ 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.