(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 a purpose that is worn on the examiner's s een and the circuins in the closed setimal examiner A patient examination glove is disposaolo device institution 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 D5250-00E4.
The provided text is a 510(k) summary for a medical device: "Grand Work Plastics Products Co., Ltd. Synthetic (White) Vinyl Patient Examination Gloves—Powder Free." This document describes the device and its compliance with established standards, but it does not involve AI/ML technology or a study proving its performance against a statistical acceptance criteria in the typical sense of AI/ML device evaluations.
Instead, this document details the device's adherence to existing ASTM standards and FDA requirements for patient examination gloves. Therefore, many of the requested elements for an AI/ML device study (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable to this type of medical device submission.
However, I can extract the information that is relevant to the acceptance criteria and how the device meets them based on the provided text.
Here's the breakdown:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard / Test) | Requirement | Reported Device Performance |
|---|---|---|
| ASTM Standard D5250-00E4 (Physical and Dimensions) | Meets all requirements of ASTM Standard D5250-00E4. | All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection Level S-2, AQL 4.0. The device conforms fully to ASTM-D-5250-00E4 standard. |
| FDA 1000 ml. Water Fill Test (based on ASTM D-5151-99) | Meets FDA pinhole requirements. | Conducted with samplings of AQL 2.5, Inspection Level I, meeting these requirements. The device meets pinhole FDA requirements. |
| Primary Skin Irritation Test | No primary skin irritant reactions. | Testing conducted with results showing no primary skin irritant reactions. The device meets biocompatibility requirements. |
| Skin Sensitization Test (Allergic Contact Dermatitis) | No sensitization reactions. | Testing conducted with results showing no sensitization reactions. The device meets biocompatibility requirements. |
| Residual Powder Test (based on ASTM D6124-01) | No more than 2 mg powder per glove for "powder-free" claims. | Conducted at finished inspection to ensure gloves meet "powder-free" claims (contain no more than 2 mg powder per glove). |
| General Controls and Labeling Claims | Meets all applicable 21 CFR references, general provisions of the Act (annual registration, listing, GMP, labeling, prohibitions against misbranding and adulteration), and does not make special labeling claims (e.g., hypoallergenic). Does not make new claims from predicate. | Conforms fully to ASTM-D-5250-00E4 standard as well as applicable 21 CFR references. No special labeling claims (e.g., hypoallergenic). No safety/efficacy issues or new claims from the "substantial equivalence" products cited. Meets labeling claims. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Physical and Dimensions Testing: Inspection Level S-2, AQL 4.0 (Specific number of gloves not stated, but defined by the AQL standard).
- Sample Size for Water Fill Test: AQL 2.5, Inspection Level I (Specific number of gloves not stated, but defined by the AQL standard).
- Sample Size for Other Tests (Skin Irritation, Sensitization, Residual Powder): Not explicitly stated, but implies sufficient sampling to meet the standard's requirements.
- Data Provenance: The tests were conducted internally by Grand Work Plastics Products Co., Ltd. (implied by "The standards used for Grand Work Plastics Products Co., Ltd. glove production are based on ASTM-D-5250-00E4. All testing meets requirements..."). This is a prospective testing of manufactured product batches. The country of origin of the data would be China, where the manufacturing company is located.
3. 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 this device is based on objective, standardized physical and chemical tests (e.g., water fill for pinholes, weighing for powder, biological assays for irritation). There are no human "experts" establishing a subjective ground truth in the way a radiologist would interpret an image. The standards themselves define the "truth."
4. Adjudication Method for the Test Set
- Not Applicable. As the tests are objective and quantitative (e.g., pass/fail a water leak, weight measurement), there's no need for adjudication among multiple human reviewers. The test results directly determine compliance with the standard's criteria.
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 a basic medical device (patient examination glove), not an AI/ML diagnostic or assistive tool. MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This device does not have an algorithm or AI component.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" is defined by established, objective ASTM and FDA standards for physical properties (dimensions, tensile strength, freedom from holes) and chemical properties (powder residue) and biological safety (biocompatibility through irritation/sensitization tests). It's based on adherence to these universally accepted and measurable criteria.
8. The Sample Size for the Training Set
- Not Applicable. This device does not involve an AI/ML model, so there is no "training set." The manufacturing process itself is implicitly "trained" through quality control and adherence to standards over time, but not in the machine learning sense.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set for an AI/ML model, this question is not relevant.
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JUN - 3 2004
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. Shuangzu Ma Grand Work Plastics Products Co., Ltd. Donggao Industrial Zone Zanhuang, Hebei Province P.R. China
Date Summary Prepared: March 01, 2004
2. Name of the Device:
Grand Work Plastics Products Co., Ltd. Synthetic (White) Vinyl Patient Examination Gloves—Powder Free
3. Predicate Device Information:
Shijiazhuang Great Eagle Plastic Products Co., Ltd. Synthetic Powder Free (White) Vinyl Patient Examination Gloves (K000071)
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 D5250-00E4.
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:
Grand Work Plastics Products Co., Ltd. Synthetic (White) Vinyl Patient Examination Gloves-Powder Free, is substantially equivalent in safety and effectiveness to the Shijiazhuang Great Eagle Plastic Products Co., Ltd. Synthetic Powder Free (White) Vinyl Patient Examination Gloves.
7. Discussion of Non-Clinical tests Performed for Determination of Substantial Equivalence are as follows:
The standards used for Grand Work Plastics Products Co., Ltd. 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, AQL 4.0.
The FDA 1000 ml. Water Fill Test based on ASTM D-5151-99 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 D6124-01 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:
Grand Work Plastics Co., Ltd. Synthetic (Whitc) Vinyl Patient Examination gloves-Powder Free 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 seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 3 2004
Grand Work Plastic Products Company Limited C/O Mr. James Chu Official Correspondent Gloveco, Incorporated 590 West Central Avenue, #D Brea, California 92821
Re: K040681
Ro40001 Gloves--Powder Free Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: April 28, 2004 Reccived: May 20, 2004
Dear Mr. Chu:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your became or ============================================================================================================================================== 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 Interstate commerce prior to they been reclassified in accordance with the provisions of Allichunches, or to ab rises 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 approvisions of the Act. The general controls provisions of the Act include controls providents of an 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 (FWA), it may of subjoct to have of Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in the South nouncements concerning your device in the Federal Register.
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Page 2 - Mr. Chu
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be auvisou that 1 DTS issuates on that your device complies with other requirements mean that I DA nas made a actes and regulations administered by other Federal agencies. of the Act of ally I ederal bakes and equirements, including, but not limited to: registration You must comply with an the Fiseling (21 CFR Part 801); good manufacturing practice allo listing (21 CFR Part 007), idocling (21 CFR Part 820); and if requirelitents as set forth in the quality by rovisions (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) IThis letter will anow Jourte over mailing of substantial equivalence of your device to a premarket nonfication. The PDF milang or sassification 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), If you desire specific acrise for your de at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Parl 807.97). You may obtain other general information on your responsibilities under the Act from the Inay outain of Small Manufacturers, International and Consumer 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,
Ques
Chiu Lin, Ph.D Dircctor 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
Page 1 of 1
0406 510(k) NUMBER (IF KNOWN) :_ Grand Work Plastics Products Co., Ltd. DEVICE NAME: DEVICE NAME:
A patient examination glove is disposable device intended for medical a purpose that is worn on the examiner's s
een and the circuins in the closed setimal examiner A patient examination glove is disposaolo device institution 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 Anesthesiology, General Hospital,
Infection Control, Dental Devices
| 510(k) Number: | K040681 |
|---|---|
| ---------------- | --------- |
§ 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.