(28 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 a 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, Powder-Free Vinyl Patient Examination Glove, 80L YZ, and meets all requirements of ASTM Standard D5250-00.
The provided 510(k) summary is for a medical device that is a Synthetic Powder Free Vinyl Patient Examination Glove. This type of submission, especially for Class I devices like examination gloves, typically relies on established performance standards rather than complex clinical studies involving human readers or AI.
Therefore, many of the requested categories regarding AI, human readers, ground truth for training sets, etc., are not applicable to this specific submission. The submission focuses on demonstrating that the new device meets recognized industry standards and is substantially equivalent to a predicate device.
Here's a breakdown based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| Physical and Dimensions Testing: Based on ASTM-D-5250-00, Inspection Level S-2, AQL 4.0 | All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection Level S-2, AQL 4.0. (General statement of compliance) |
| Pinhole Detection (FDA 1000 ml. Water Fill Test): AQL 2.5, Inspection Level I | The FDA 1000 ml. Water Fill Test was conducted with samplings of AQL 2.5, Inspection Level I, meeting these requirements. |
| Primary Skin Irritation | Testing conducted with results showing no primary skin irritant reactions. |
| Skin Sensitization (allergic contact dermatitis) | Testing conducted with results showing no sensitization reactions. |
| Residual Powder Test (for "powder-free" claim): ASTM D6124-97, no more than 2 mg powder per glove | A Residual Powder Test that based on ASTM D6124-97 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). (Statement of compliance with the 2 mg/glove limit implied) |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set:
- For Physical and Dimensions Testing: "Inspection Level S-2, AQL 4.0" (Specific sample size is not explicitly stated, but these are statistical sampling plans from ASTM/ISO standards).
- For FDA 1000 ml. Water Fill Test: "AQL 2.5, Inspection Level I" (Specific sample size is not explicitly stated, but these are statistical sampling plans from ASTM/ISO standards).
- For Biocompatibility (Primary Skin Irritation and Skin Sensitization): Not specified but typically involves a set number of animal or in vitro tests according to ISO 10993 standards.
- For Residual Powder Test: Not specified but would be a sampling from production batches.
- Data Provenance: The tests are described as being "conducted" in relation to the manufacturer (Shijiazhuang Eversharp Plastics Products Co., Ltd. in China), indicating the data provenance is likely internal testing performed by or for the manufacturer. The date of "May 11, 2001" for the summary indicates a retrospective nature relative to the submission date.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This device is a physical product (gloves) and its performance is assessed against standardized physical, chemical, and biological tests, not against diagnostic "ground truth" established by human experts in the way AI algorithms are evaluated.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. As mentioned above, the evaluation is based on objective measurements and adherence to established standards, not on human interpretation or adjudication methods.
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 is not an AI-enabled diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI-enabled device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this device's performance is derived from established industry standards and regulatory test methods. For example:
- Physical performance: Defined by ASTM-D-5250-00 (e.g., tensile strength, elongation, dimensions).
- Barrier integrity: Defined by the FDA 1000 ml. Water Fill Test (pinhole detection).
- Biocompatibility: Defined by primary skin irritation and skin sensitization tests (aligned with ISO 10993 principles, though not explicitly stated as such, it's the standard for these tests).
- Powder content: Defined by ASTM D6124-97.
8. The sample size for the training set
- Not Applicable. There is no "training set" as this is not an AI/machine learning device. The "training" for the manufacturing process would be related to quality control and process validation, not data used to train an algorithm.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set in the context of an AI algorithm, this question is not relevant. The "ground truth" for manufacturing quality and consistency is established through adherence to Good Manufacturing Practices (GMP) and quality system regulations (such as 21 CFR Part 820), which ensure consistent product quality, but this is distinct from ground truth for an AI training set.
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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: 《Ο| | ೪ √ 5
1. Submitter's Identification:
Mr. Yinhai Wang Shijiazhuang Eversharp Plastics Products Co., Ltd. No. 312 East Long Quan Road Luquan, Hebei Province P.R. China
Date Summary Prepared: May 11, 2001
2. Name of the Device:
Shijiazhuang Eversharp Plastics Products Co., Ltd. Synthetic Powder Free Vinyl Patient Examination Gloves
3. Predicate Device Information:
Shijiazhuang Great Eagle Plastic Products Co., Ltd. Synthetic Powder Free Vinyl Patient Examination Gloves (K983207)
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, 80L YZ, and meets all requirements 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.
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Comparison to Predicate Devices: 6.
Shijiazhuang Eversharp Plastics Products Co., Ltd. Synthetic Powder Free Vinyl Patient Examination Gloves, is substantially equivalent in safety and effectiveness to the Shijiazhuang Great Eagle Plastic Products Co., Ltd. Synthetic Powder Free Vinyl Patient Examination Gloves.
7. Discussion of Non-Clinical tests Performed for Determination of Substantial Equivalence are as follows:
The standards used for Shijiazhuang Eversharp Plastics 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, 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.
There are no special labeling claims and we do not claim our gloves as hypoallergenic on our labels.
A Residual Powder Test that based on ASTM D6124-97 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. Discussion of Clinical Tests Performed:
Not Applicable - There is no hypoallergenic Claim.
9. Conclusions:
Shijiazhuang Eversharp Plastics Co., Ltd. Synthetic Powder Free Vinyl Patient Examination gloves 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/2 description: The image is a black and white seal for the Department of Health & Human Services. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the top half of the circle. The bottom half of the circle contains a stylized symbol that resembles an eagle or bird with three wing-like shapes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 6 2001
Shijizahuang Eversharp Plastic Products Co., Ltd. Mr. James Chu Official Correspondent Gloveco, Incorporated 12390 East End Avenue Chino, California 91710
K011885 Re : Synthetic Powder Free Vinyl Trade/Device Name: Patient Examination Gloves Requlation Number: 880.6250 Regulatory Class: I Product Code: LYZ Dated: May 18, 2001 June 18, 2001 Received:
Dear Mr. Chu:
We have reviewed your Section 510(k) notification of intent to we have reviewed your beceien beve and we have determined the market the device referenced above (for the indications for device is substancially organ to legally marketed predicate use stated in the encrobare, or inverce prior to May 28, 1976, devices marketed in theor Medical Device Amendments, or to the enactment date or che nassified in accordance with the devices that have been roofaod, Drug, and Cosmetic Act (Act).
provisions of the Federal Food, Drug, and Cosmetic the general provisions of the reachar rosa, subject to the general The general controls controls provisions of the Act. controls provisions of include requirements for annual provisions of the Act moraus as good manufacturing practice, registration, freeing on against misbranding and adulteration.
If your device is classified (see above) into either class II II your device Ib crabbins III (Premarket Approval), it may (Special Controls) en in additional controls. Existing the be subject to such addrois device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਉ Federal Regulations, freis the resumes compliance with Subscancially equivalencturing Practice requirements, as set the Current Good Manafastem Regulation (QS) for Medical
forth in the Quality System Regulation (QS) and that Forth in the Quarry Intion (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Chrough DCFrodic go Inbposverify such assumptions. Failure to Administration (FBF) the Carresult in regulation may result in regulatory
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Page 2 - Mr. Chu
In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to beqin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address
"http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Susan Rusner
1 Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) NUMBER (if KNOWN) : K O11885 Shijiazhuang Eversharp Plastics Products Co., Ltd. DEVICE NAME: DEVICE NAME:
INDICATIONS FOR USE: Synthetic Powder Free Vinyl Patient Examination Gloves
A patient examination glove is disposable device intended for medical a purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
| Concurrent of CDRH, Office of Device Evaluation (ODE) |
|---|
| ------------------------------------------------------- |
| Prescription Use(Per 21 CFR 801.109) | OR | Over-The-Counter-Use | X |
|---|---|---|---|
| (Optional Format 1-2-96) |
| (Division Sign-Off) | |
|---|---|
| Division of Dental, Infection Control, | |
| and General Hospital Devices | |
| 510(k) Number | K011885 |
§ 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.