(79 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 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, Power-Free Vinyl Patient Examination Gloves, 80 LYZ, and meets all requirements of ASTM standard D-5250-00E4.
This looks like a 510(k) premarket notification for disposable vinyl examination gloves, not an AI/ML medical device. Therefore, the questions about AI/ML specific criteria, study design, and performance metrics (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance) are not applicable.
However, I can extract the acceptance criteria and the "study" (non-clinical tests in this context) that proves the device meets them, based on the provided text.
Here's an interpretation based on the document:
1. Acceptance Criteria and Reported Device Performance (Non-Clinical Tests)
| Acceptance Criteria (Standard/Test) | Reported Device Performance | Comments |
|---|---|---|
| ASTM D-5250-00E4 (General Requirements) | Conforms fully to this standard | This encompasses physical and dimensional testing. |
| FDA 1000 mL Water Fill Test (Pinhole AQL) | AQL 2.5, Inspection Level I, meets requirements | This tests for pinholes/integrity, crucial for barrier protection. |
| Residual Powder Test (ASTM D-6124-06 for Starch) | Contains no more than 2 mg powder per glove | Meets "powder-free" claims. |
| Primary Skin Irritation Test | No primary skin irritant reactions | Biocompatibility testing. |
| Skin Sensitization Test (Allergic Contact Dermatitis) | No sensitization reactions | Biocompatibility testing. |
| 21 CFR references (Applicable) | Meets all applicable 21 CFR requirements | General regulatory compliance. |
2. Sample size used for the test set and the data provenance:
- Pinhole Testing (FDA 1000 ml Water Fill Test): "samplings of AQL 2.5, inspection level I". This indicates a specific sampling plan from an Acceptable Quality Level (AQL) standard, but the exact number of gloves tested is not explicitly stated.
- Physical and Dimensional Testing (ASTM-D-5250-00E4): "Inspection level S-2, AOL 4.0". Similar to above, this references an AQL sampling plan, but the exact sample size is not numerically provided.
- Residual Powder Test (ASTM D-6124-06): Not explicitly stated, but implies routine inspection.
- Biocompatibility (Primary Skin Irritation and Skin Sensitization): The exact number of subjects or samples used in these tests is not specified in the document.
- Data Provenance: The device is manufactured by "Super Safe Plastic Products Co., Ltd." in "Shijiazhuang, Hebei, China". The testing was performed by the manufacturer or a contracted lab to demonstrate compliance with US standards. The data is retrospective in the sense that the tests were completed before submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable as this is a physical medical device (gloves), not an AI/ML diagnostic or interpretive device. The "ground truth" is established through standardized physical, chemical, and biological tests.
4. Adjudication method for the test set:
- Not applicable for this type of device. Compliance is determined by objective measurements against established standards.
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 as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable as this is not an AI/ML device.
7. The type of ground truth used:
- The ground truth is based on objective measurements and standardized test methods as defined by ASTM standards (D-5250-00E4, D-6124-06) and FDA test protocols (1000 ml Water Fill Test), as well as biocompatibility testing standards. For example, for the "powder-free" claim, the ground truth is "no more than 2 mg powder per glove" as measured by the ASTM D-6124-06 method.
8. The sample size for the training set:
- Not applicable as this is not an AI/ML device. There is no "training set" in the context of manufacturing and quality control for gloves; rather, there are manufacturing processes that are controlled to meet specifications.
9. How the ground truth for the training set was established:
- Not applicable as this is not an AI/ML device.
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MAR 2 3 2007
EXHIBIT #I 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:
1. Submitter's Identification:
Mr. Lu Wenxin Super Safe Plastic Products Co., Ltd. Meng Er Village, Pingshan County Shijiazhuang, Hebei, China 050401
Date Summary Prepared: September 20, 2006
2. Name of the Device:
Super Safe Plastic Products Co., Ltd. Powder Free Vinyl Patient Examination Gloves, Yellow
3. Predicate Device Information:
Shijiazhuang Great Eagle Plastic Products Co., Ltd Synthetic Powder-Free (Yellow) Vinyl Patient Examination Gloves (K992861)
4. Device Description:
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Power-Free Vinyl Patient Examination Gloves, 80 LYZ, and meets all requirements of ASTM standard D-5250-00E4.
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.
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6. Comparison to Predicate Devices:
Super Safe Plastic Products Co., Ltd.'s Powder Free Vinyl Patient Examination Gloves, Yellow- is substantially equivalent in safety and effectiveness to the Shijiazhuang Great Eagle Plastic Products Co., Ltd.'s Synthetic Powder-Free (Yellow) Vinyl Patient Examination Gloves.
7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as Follows:
The standards used for Super Safe Plastic Products Co., Ltd.'s glove production are based on ASTM-D-5250-00E4. All testing meets requirements for physical and dimensions testing conducted on gloves. Inspection level S-2, AOL 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 Starch 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:
Super Safe Plastic Products Co., Ltd.'s Powder Free Vinyl Patient Examination Gloves, Yellow conform fully to ASTM D-5250-00E4 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 and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 3 2007
Super Safe Plastic Products Company Limited C/O Ms. Kathy Liu Official Correspondent Gloveco, Incorporated 3973 Schaefer Avenue Chino, California 91710
Re: K070038
Trade/Device Name: Powder Free Vinyl Patient Examination Gloves. Yellow Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: March 2, 2007 Received: March 8, 2007
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.
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 - 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); 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.
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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 vours.
Chiu Lin, Ph.D.
Chiu Lin, Ph.D. 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
510 (k) NUMBER (IF KNOW): APPLICANT: DEVICE NAME:
റ്റാറ്റുമുഴ
Super Safe Plastic Products Co., Ltd. Powder Free Vinyl Patient Examination Glove, Yellow.
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 (Per 21 CFR 801.109) OR
Over-The-Counter-Use (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrent of CDRH, Office of Device Evaluation (ODE) f Anestheriology, General Hospital Control, Damai Devices ) Numbe
§ 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.