(99 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, Power-Free Nitrile Examination Gloves, Blue, 80 LZA, and meets all requirements of ASTM standard D-6319-00a (Reapproved 2005).
The acceptance criteria for the Hongye Plastic Products Co., Ltd. Powder Free Nitrile Examination Gloves, Blue, are based on adherence to ASTM standard D-6319-00a (Reapproved 2005) and FDA requirements for patient examination gloves.
Here's a breakdown of the acceptance criteria and performance based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Material Standard | ASTM D-6319-00a (Reapproved 2005) | Device meets all requirements of ASTM standard D-6319-00a (Reapproved 2005). |
| Physical and Dimensions Testing | Meets requirements based on ASTM D-6319-00a | All testing meets requirements for physical and dimensions testing conducted on gloves. |
| Freedom from Holes (Pinhole Test) | FDA 1000 ml. Water Fill Test requirements (AQL 2.5, inspection level G-1) | Water Fill Test conducted with samplings of AQL 2.5, inspection level G-1, meeting these requirements. |
| Biocompatibility - Primary Skin Irritation | No primary skin irritant reactions | Testing conducted with results showing no primary skin irritant reactions. |
| Biocompatibility - Skin Sensitization (Allergic Contact Dermatitis) | No sensitization reactions | Testing conducted with results showing no sensitization reactions. |
| Powder Residue (Powder-Free Claim) | No more than 2 mg powder per glove (based on ASTM D-6124-01 for Starch) | Residual Powder Test conducted to ensure gloves meet "powder-free" claims (contain no more than 2 mg powder per glove). |
| Labeling | No special labeling claims, no hypoallergenic claim | No special labeling claims and no claim of being hypoallergenic on labels. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set:
- For physical and dimensions testing, the inspection level was S-2, AQL 4.0. This indicates a sampling plan, but the exact number of gloves tested is not explicitly stated as a raw number. AQL (Acceptable Quality Limit) 4.0 refers to the maximum percentage of defective items that, for purpose of sampling inspection, can be considered satisfactory.
- For the FDA 1000 ml. Water Fill Test, the inspection level was G-1, AQL 2.5. Again, this is a sampling plan, not a raw number.
- For Biocompatibility (Primary Skin Irritation and Skin Sensitization) and the Residual Powder Test, specific sample sizes are not explicitly stated in the provided text.
- Data Provenance: The document does not explicitly state the country of origin of the data beyond the manufacturer being in China. The study appears to be retrospective in the sense that it's a report of tests conducted on manufactured gloves to demonstrate compliance with standards. It's not a prospective clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable to this device. The "ground truth" for examination gloves is established by objective performance against predefined technical standards (ASTM, FDA water fill test, biocompatibility protocols) rather than expert consensus on diagnostic images or clinical outcomes. The tests described are standardized laboratory and physical property tests.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in studies involving subjective interpretation (e.g., radiologists reviewing images) to resolve discrepancies. For objective tests on examination gloves, the results are quantitative measures or pass/fail criteria based on defined thresholds.
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 is not applicable. This device is a medical glove, not an AI-powered diagnostic or assistive tool. MRMC studies are used for evaluating AI performance in clinical diagnostic scenarios.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. This device is a medical glove, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device is based on objective technical standards and laboratory test results. This includes:
- Physical property measurements (e.g., dimensions, tensile strength, elongation, force at break) against ASTM D-6319-00a specifications.
- Absence of holes (pinholes) as determined by the FDA 1000 ml Water Fill Test.
- Biocompatibility (absence of primary skin irritation and sensitization) as determined by standardized in-vivo or in-vitro tests (methods not detailed beyond "testing conducted with results showing no primary skin irritant or sensitization reactions").
- Residual powder levels determined by ASTM D-6124-01.
8. The Sample Size for the Training Set
This is not applicable. The concept of a "training set" refers to data used to train machine learning algorithms. This device is a physical product, not an AI model. Its performance is demonstrated through adherence to established manufacturing and testing standards.
9. How the Ground Truth for the Training Set was Established
This is not applicable for the same reason as point 8.
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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 SM DA 1990 and 21 CFR §807.92.
COGOLY 7 The assigned 510(K) number is:
1. Submitter's Identification:
Mr. Shuangzhu Ma Hongye Plastic Products Co., Ltd. Donggao Industrial Zone Zanhuang, Hebei, China 050000
Date Summary Prepared: December 30, 2005
2. Name of the Device:
Hongye Plastic Products Co., Ltd. Powder Free Nitrile Examination Gloves, Blue
3. Predicate Device Information:
Shanghai Poseidon Plastic Products Co., Ltd. Nitrile Exam Gloves, Powder-Free, Color Blue (K001128)
4. Device Description:
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Power-Free Nitrile Examination Gloves, Blue, 80 LZA, and meets all requirements of ASTM standard D-6319-00a (Reapproved 2005).
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:
Hongye Plastic Products Co., Ltd.'s Powder Free Nitrile Examination Gloves, Blue, is substantially equivalent in safety and effectiveness to the Shanghai Poseidon Plastic Products Co., Ltd.'s Nitrile Exam Gloves, Powder-Free, Color Blue.
7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as Follows:
The standards used for Hongye Plastic Products Co., Ltd.'s glove production are based on ASTM-D-6319-00a (Reapproved 2005). 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 G-1, 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-6124-01 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. 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:
Hongye Plastic Products Co., Ltd.'s Powder Free Nitrile Examination Gloves, Blue conform fully to ASTM-D-6319-00a (Reapproved 2005) 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 Department of Health and Human Services (HHS). The logo consists of a stylized image of an eagle or bird in flight, with three curved lines representing the wings and body. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
28 2006 ー
ディ
Hongye Plastic Products Company, Limited C/O Ms. Kathy Liu Gloveco, Incorporated 3973 Schafer Avenue Chino, California 91710
Re: K060147
Trade/Device Name: Powder Free Nitrile Examination Gloves, Blue Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: April 4, 2006 Received: April 5, 2006
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 (301) 594-4618. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Clive
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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Page 1 of 1
INDICATION FOR USE
510(K) NUMBER KOGO 147 (IF KNOWN): APPLICANT: Hongye Plastic Products Co., Ltd. DEVICE NAME: Powder Free Nitrile Examination Gloves, Blue
:
INDICATIONS FOR USE:
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.
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter-Use X (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)
General Hosp
21:52/1
§ 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.