(71 days)
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-5250-06.
The provided document is a 510(k) premarket notification for "Synthetic Powder Free (Pink) Vinyl Patient Examination Gloves." This submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel clinical effectiveness through extensive clinical trials. Therefore, much of the information requested, such as multi-reader multi-case studies, effect sizes of AI assistance, and detailed ground truth establishment for large training sets, is not applicable to a device of this type (Class I patient examination gloves).
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The primary acceptance criteria for this device are compliance with ASTM standard D-5250-06 and FDA requirements for patient examination gloves.
| Acceptance Criteria (Standard D-5250-06 unless otherwise specified) | Reported Device Performance |
|---|---|
| Physical and Dimensions Testing: | Meets requirements |
| - Tensile Strength | Meets requirements |
| - Elongation | Meets requirements |
| - Dimensions (Length, Width, Thickness) | Meets requirements |
| - Inspection Level S-2, AQL 4.0 | Met |
| Pinhole Detection (Water Leak Test): | |
| - FDA 1000 ml. Water Fill Test | Meets requirements |
| - AQL 2.5, Inspection Level I | Met |
| Biocompatibility: | |
| - Primary Skin Irritation | No primary skin irritant reactions |
| - Skin Sensitization (Allergic Contact Dermatitis) | No sensitization reactions |
| Powder Content (Powder-Free Claim): | |
| - ASTM D-6124-06 for Starch (≤ 2 mg powder per glove) | Meets "powder-free" claims (≤ 2 mg powder per glove) |
| Labeling Compliance: | No special labeling claims, not claiming hypoallergenic |
| Applicable 21 CFR references | Conforms fully |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: The document mentions "samplings of AQL 2.5, inspection level I" for the water fill test and "Inspection level S-2, AQL 4.0" for physical and dimension testing. AQL (Acceptable Quality Limit) specifies the maximum proportion of defective units, and inspection levels relate to the sample size relative to the batch size, but the exact number of gloves sampled for each test is not explicitly stated in the provided document.
- Data Provenance: The tests were performed by Ever Light Plastic Products Co., Ltd. for their glove production. The country of origin of the data is China, where the manufacturer is located. The data is prospective in the sense that it was generated as part of the manufacturing and quality control process for these specific gloves to demonstrate compliance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable in the context of this device. The "ground truth" for glove performance is established by the specified ASTM standards and FDA regulations, and the tests are typically performed by trained technicians in a laboratory setting, not by medical experts establishing a "diagnosis."
4. Adjudication Method for the Test Set:
This information is not applicable. The tests for glove performance involve objective measurements against predefined criteria (e.g., pass/fail for pinholes, quantitative measurement of tensile strength, powder content). There is no "adjudication" necessary in the sense of resolving disagreements among multiple experts.
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:
This information is not applicable. This is a physical medical device (patient examination glove), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study or evaluation of AI assistance is irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This information is not applicable. This is a physical medical device, not an algorithm or AI system.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device's performance is based on established industry standards (ASTM D-5250-06) and regulatory requirements (FDA's 21 CFR and specific test methods like the 1000 ml Water Fill Test). These standards define the acceptable physical properties, barrier integrity, and biocompatibility of examination gloves.
8. The Sample Size for the Training Set:
This information is not applicable. There is no "training set" in the context of a physical device like an examination glove. These devices are manufactured and tested against established specifications, not "trained" like a machine learning model.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable. As there is no training set for a physical device, the establishment of ground truth for such a set is not relevant.
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SEP 2 6 2008
Ko 82029
EXHIBIT #1 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. Qiao Zhiqiang Ever Light Plastic Products Co., Ltd. Donggao Industrial Zone Zanhuang, Hebei, China 050000
Date Summary Prepared: June 5, 2008
2. Name of the Device:
Ever Light Plastic Products Co., Ltd. Synthetic Powder Free (Pink) Vinyl Patient Examination Gloves
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-5250-06.
5. Intended 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.
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6. Comparison to Predicate Devices:
Ever Light Plastic Products Co., Ltd.'s Synthetic Powder Free (Pink) Vinyl Patient Examination Gloves 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 Ever Light Plastic Products Co., I.d.'s glove production are based on ASTM-D-5250-06. 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 "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:
Ever Light Plastic Products Co., Ltd.'s Synthetic Powder Free (Pink) Vinyl Patient Examination Gloves conform fully to ASTM D-5250-06 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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, with stylized lines representing its wings and body.
SEP 2 6 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ever Light Plastic Products Company, Limited C/O Ms. Kathy Liu Gloveco Incorporated 3973 Schaefer Avenue Chino, California 91710
Re: K082029
Trade/Device Name: Synthetic Powder Free (Pink) Vinyl Patient Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LYZ Dated: September 11, 2008 Received: September 12, 2008
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 Ameradments, 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 111 (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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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,
J.N. Samuels Kendris
forll
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
182029
510 (k) NUMBER (IF KNOW): APPLICANT: DEVICE NAME:
Ever Light Plastic Products Co., Ltd. Synthetic Powder Free (Pink) 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.
Shula A Mugehey Ho
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K082029
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter-Use イ (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)
§ 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.