(63 days)
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, White), 80 LZA, and meets all requirements of ASTM standard D 6319-00a(2005).
The provided text describes the acceptance criteria and the study conducted for "Purtech Cleanroom Products Co., Ltd. Powder Free Nitrile Examination Gloves (Blue, White)."
Here's an analysis based on the provided information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standard) | Reported Device Performance (Summary) |
|---|---|
| ASTM D-6319-00a(2005) | Meets all requirements for physical and dimensions testing. |
| FDA 1000 ml. Water Fill Test | Meets requirements (AQL 2.5, inspection level I). |
| Primary Skin Irritation | No primary skin irritant reactions. |
| Skin Sensitization (allergic contact dermatitis) | No sensitization reactions. |
| Residual Powder (ASTM D 6124-06) | Meets "powder-free" claims (≤ 2 mg powder per glove). |
2. Sample Size Used for the Test Set and Data Provenance:
- Physical and Dimensions Testing (ASTM D-6319-00a(2005)): Inspection level S-2, AQL 4.0. (Specific sample size not provided, but indicated by the AQL and inspection level).
- FDA 1000 ml. Water Fill Test: Samplings of AQL 2.5, inspection level I. (Specific sample size not provided, but indicated by the AQL and inspection level).
- Primary Skin Irritation and Skin Sensitization Testing: The document does not specify the sample size for this testing.
- Residual Powder Test (ASTM D 6124-06): The document does not specify the sample size for this testing.
- Data Provenance: The tests are conducted on the manufacturer's own products and are non-clinical in vitro or ex vivo tests, not involving human subjects for retrospective or prospective studies in the typical sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
Not applicable. This device is a Class I medical device (patient examination gloves) and the testing described are non-clinical performance and safety tests (material properties, integrity, biocompatibility), not requiring expert-established ground truth in the context of clinical efficacy or diagnostic accuracy.
4. Adjudication Method for the Test Set:
Not applicable. The tests involve objective measurements against established standards (e.g., ASTM, FDA) for physical properties, integrity, and chemical residue, rather than subjective interpretation requiring adjudication among experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No. This type of study is not relevant for the evaluation of examination gloves. MRMC studies are typically used to assess diagnostic devices where human readers interpret images or data, often with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This device is a physical medical device (gloves), not an algorithm or AI system.
7. The Type of Ground Truth Used:
The "ground truth" for the tests is derived from established national and international standards and methodologies for evaluating medical gloves:
- Standard ASTM D-6319-00a(2005): Defines the ground truth for physical and dimensional properties.
- FDA 1000 ml. Water Fill Test: Defines the ground truth for barrier integrity (pinhole detection).
- Biocompatibility Standards (Primary Skin Irritation, Skin Sensitization): Define the ground truth for safety in terms of skin reactions.
- ASTM D 6124-06: Defines the ground truth for acceptable residual powder levels for "powder-free" claims.
8. The Sample Size for the Training Set:
Not applicable. This device is not an AI or algorithm-based system that requires a training set. The "training" for the manufacturing process would be internal quality control and adherence to established specifications.
9. How the Ground Truth for the Training Set Was Established:
Not applicable for the reasons stated above.
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MAY 3 0 2007
EXHIBIT #1 Page 1 of 2
510(K) SUMMARY
This summary of 510(K) safety and cffectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(K) number is: _ 070 862
l. Submitter's Identification:
Mr. Zhaolong Wang Purtech Cleanroom Products Co., Ltd. Fanjiazhuang Industrial Zonc Xinji City, Hebei Province, P.R. China 052360
Date Summary Prepared: March 22, 2007
2. Name of the Device:
Purtech Cleanroom Products Co., Ltd. Powder Free Nitrile Examination Gloves (Blue, White)
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, White), 80 LZA, and meets all requirements of ASTM standard D 6319-00a(2005).
5. Intended 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.
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6. Comparison to Predicate Devices:
Purtech Cleanroom Products Co., Ltd.'s Powder Free Nitrile Examination Gloves (Blue, White), 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 Purtech Cleanroom Products Co., Ltd.'s glove production are based on ASTM D-6319-00a(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 I, mecting 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:
Purtech Cleanroom Products Co., Ltd.'s Powder Free Nitrile Examination Gloyes (Blue, White) conform fully to ASTM D6319-00a(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 seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, representing health and medicine, with three figures intertwined, symbolizing the relationship between health, services, and people. The seal is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 3 0 2007
Purtech Cleanroom Products Company, Limited C/O Ms. Kathy Liu Official Correspondent Gloveco, Incorporated 3973 Schaefer Avenue Chino, California 91710
Re: K070862
Trade/Device Name: Powder Free Nitrile Examination Gloves (Blue, White) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: May 15, 2007 Received: May 16, 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 gencral 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 cquivalence 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 requircments 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.
Chiu-Ling, Ph.D.
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
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Page 1 of 1
INDICATION FOR USE
510(K) NUMBER APPLICANT: DEVICE NAME:
(IF KNOWN): K070862 Purtech Cleanroom Products Co., Ltd. Powder Free Nitrile Examination Gloves (Blue, White)
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 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) |
|---|
| (Sign-Off) |
| Division of Anesthesiology, General Hospital, |
| Location Control, Dental Devices |
(k) Number ___________________________________________________________________________________________________________________________________________________________________
§ 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.