(78 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, Powered Vinyl Patient Examination Gloves, 80 L YZ, and meets all requirements of ASTM standard D-5250-00E4.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them, structured as requested.
The document describes a 510(k) submission for Powdered (White) Vinyl Patient Examination Gloves. As such, the "device" in this context is a medical glove, not a software algorithm or AI system. Therefore, many of the requested points related to AI/software validation are not applicable.
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standard / Test) | Requirement / Benchmark | Reported Device Performance |
|---|---|---|
| Physical and Dimensions Testing | ASTM-D-5250-00E4 | Meets requirements |
| Pinhole / Water Fill Test | FDA 1000 ml. Water Fill Test AQL 2.5, inspection level I | Meets requirements |
| Primary Skin Irritation | No primary skin irritant reactions | No primary skin irritant reactions (Biocompatibility requirements met) |
| Skin Sensitization | No sensitization reactions (allergic contact dermatitis) | No sensitization reactions (Biocompatibility requirements met) |
| Residual Powder Test | ASTM D-6124-06 (no more than 10mg/dm²) | Meets "powdered" claims (Implicitly, less than 10mg/dm²) |
| Substantial Equivalence | Equivalent to predicate device K000166 in safety and effectiveness | Achieved substantial equivalence to predicate device |
2. Sample size used for the test set and the data provenance:
-
Physical and Dimensions Testing: Inspection level S-2, AQL 4.0. (Specific sample size in units is not provided, but AQL 4.0 refers to a sampling plan for acceptability).
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FDA 1000 ml. Water Fill Test: AQL 2.5, inspection level I. (Specific sample size in units is not provided).
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Primary Skin Irritation and Skin Sensitization: Not explicitly stated, but these are typically performed in vivo (on animal models or human volunteers). The context implies prospective testing specifically for this device.
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Residual Powder Test: Not explicitly stated, but performed at finished inspection.
Data Provenance: The tests were conducted on the manufacturer's own gloves ("Shijiazhuang Lianhe Shunda Plastic Products Co., Ltd.'s glove production"), indicating a prospective testing approach specific to this device. The country of origin of the manufacturer is China.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the device is a medical glove, not a diagnostic or prognostic system requiring expert interpretation or ground truth establishment in that typical sense. The "truth" here is determined by objective physical, chemical, and biological tests according to established standards.
4. Adjudication method for the test set:
Not applicable. This concept typically applies to subjective assessments where multiple human readers or experts evaluate data. For physical product testing, the methods are objective applications of test 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 relates to AI/software performance studies. The device is a physical medical glove.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This relates to AI/software performance studies. The device is a physical medical glove.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the glove's performance is established by objective measurements and chemical/biological assays demonstrating compliance with predefined ASTM standards and FDA requirements. For example:
- Physical properties (tensile strength, dimensions) are measured.
- Pinhole presence is determined by liquid leakage.
- Biocompatibility (skin irritation/sensitization) is assessed through standard biological testing.
- Residual powder is measured gravimetrically.
8. The sample size for the training set:
Not applicable. This concept refers to the data used to train an AI model. The device is a physical medical glove, not an AI system.
9. How the ground truth for the training set was established:
Not applicable. As above, this pertains to AI model development.
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EXHIBIT #1 Page 1 of 2
510(K) SUMMARY
MAR 2 2 2007
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: K070027
l. Submitter's Identification:
Mr. Li Quanfu Shijiazhuang Lianhe Shunda Plastic Products Co., Ltd. Nanwuhui Village, Yuanshi County, Shijiazhuang, Hebei, China 051130
Date Summary Prepared: September 20, 2006
2. Name of the Device:
Shijiazhuang Lianhe Shunda Plastic Products Co., Ltd. Powdered (White) Vinyl Patient Examination Gloves
3. Predicate Device Information:
Shijiazhuang Great Eagle Plastic Products Co., Ltd Powdered (White) Vinyl Patient Examination Gloves (K000166)
4. Device Description:
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powered Vinyl Patient Examination Gloves, 80 L YZ, 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:
Shijiazhuang Lianhe Shunda Plastic Products Co., Ltd.'s Powdered (White) Vinyl Patient Examination Gloves is substantially equivalent in safety and effectiveness to the Shijiazhuang Great Eagle Plastic Products Co., Ltd.'s Powdered (White) Vinyl Patient Examination Gloves.
7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as Follows:
The standards used for Shijiazhuang Lianhe Shunda Plastic Products Co., Ltd.'s glove production are based on ASTM-D-5250-00 =4. 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.
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 "powdered" claims (contain no more than 10mg/dm4).
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:
Shijiazhuang Lianhe Shunda Plastic Products Co., Ltd.'s Powdered (White) Vinyl Patient Examination Gloves 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Shijiazhuang Lianhe Shunda Plastic Products Company Limited C/O Ms. Kathy Liu Official Correspondent Gloveco, Incorporated 3973 Schaefer Avenue Chino, California 91710
MAR 2 2 2007
Re: K070027
Trade/Device Name: Powdered (White) Vinyl Patient Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: March 12, 2007 Received: March 13, 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 yours,
Clus
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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INDICATION FOR USE
510 (k) NUMBER (IF KNOW): APPLICANT: DEVICE NAME:
10700 77 Shijiazhuang Lianhe Shunda Plastic Products Co., Ltd. Powdered (White) Vinyl Patient Examination Gloves
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 V (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)
Howard Sheila R. Murphy, MD
tion Control
Services
§ 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.