(104 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, Power-Free Vinyl Patient Examination Gloves, 80 LYZ, and meets all requirements of ASTM standard D-5250-00E4.
The document describes the acceptance criteria and the study conducted for the Shijiazhuang Junfei Plastic Products Co., Ltd. Powder Free (White) Vinyl Patient Examination Gloves.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Test/Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Physical Performance | ASTM-D-5250-00E4 (General Physical & Dimensions) | Meets all requirements | Meets all requirements |
| Barrier Integrity | FDA 1000 ml. Water Fill Test | AQL 2.5, Inspection Level I requirements | Meets requirements |
| Biocompatibility | Primary Skin Irritation | No primary skin irritant reactions | No primary skin irritant reactions |
| Biocompatibility | Skin Sensitization (Allergic Contact Dermatitis) | No sensitization reactions | No sensitization reactions |
| Powder Content | Residual Powder Test (ASTM D6124-06) | No more than 2 mg powder per glove | Meets "powder-free" claims (contains ≤ 2 mg powder/glove) |
2. Sample Size Used for the Test Set and Data Provenance:
- Physical Performance (ASTM-D-5250-00E4): "Inspection level S-2, AOL 4.0" is mentioned, which refers to a sampling plan for attributes. The exact numerical sample size is not explicitly stated in the provided text, but it indicates a statistical sampling approach.
- Barrier Integrity (FDA 1000 ml. Water Fill Test): "samplings of AQL 2.5, inspection level I" is mentioned, again referring to a statistical sampling plan. The exact numerical sample size is not explicitly stated.
- Biocompatibility (Skin Irritation and Sensitization): The specific sample sizes for these tests are not provided in the document.
- Residual Powder Test (ASTM D6124-06): The specific sample size for this test is not provided.
- Data Provenance: The tests were conducted internally by Shijiazhuang Junfei Plastic Products Co., Ltd. (or on their behalf) as part of their production and quality control processes. The origin of the data is China, and it appears to be a prospective set of tests conducted on manufactured glove batches.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable and not provided in the document. The tests performed are objective, laboratory-based, and standard-driven (e.g., ASTM standards, FDA water fill test), which do not typically require expert consensus for establishing ground truth in the same way clinical imaging or diagnostic studies might.
4. Adjudication Method for the Test Set:
This information is not applicable and not provided. The assessment of polyvinyl examination glove performance is based on defined physical and chemical test methods against established pass/fail criteria, not on subjective expert review or adjudication.
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. The device is a physical medical device (examination gloves), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance for human readers is irrelevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable. The device is a physical medical device, not an algorithm, so a standalone algorithm performance study is not relevant.
7. The Type of Ground Truth Used:
The ground truth for this device is based on objective measurements against established industry standards and regulatory requirements. This includes:
- Physical properties defined by ASTM D-5250-00E4 (e.g., dimensions, tensile strength, elongation).
- Barrier integrity (pinhole detection) verified by the FDA 1000 ml. Water Fill Test.
- Biocompatibility based on standardized biological tests for primary skin irritation and sensitization.
- Chemical residue (powder content) measured according to ASTM D6124-06.
8. The Sample Size for the Training Set:
This information is not applicable and not provided. This device is a manufactured product undergoing quality control and performance testing, not a machine learning model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable. As explained above, there is no "training set" in the context of this device. The ground truth for evaluating the device's performance is established by the specified ASTM standards and FDA test methods.
{0}------------------------------------------------
FEB 2 8 2007
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: KO6347 |
1. Submitter's Identification:
Mr. Guixi Liu Shijiazhuang Junfei Plastic Products Co., Ltd. Donggao Industrial Zone Zanhuang, Hebei, China 050000
Date Summary Prepared: August 30, 2006
2. Name of the Device:
Shijiazhuang Junfei Plastic Products Co., Ltd. Powder Free (White) Vinyl Patient Examination Gloves
3. Predicate Device Information:
Shijiazhuang Great Eagle Plastic Products Co., Ltd 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, Power-Free Vinyl Patient Examination Gloves, 80 LYZ, 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.
{1}------------------------------------------------
6. Comparison to Predicate Devices:
Shijiazhuang Junfei Plastic Products Co., Ltd.'s Powder Free (White) Vinyl Patient Examination Gloves is substantially equivalent in safety and effectiveness to the Shijiazhuang Great Eagle Plastic Products Co., Ltd.'s 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 Shijiazhuang Junfei 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, AOL 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 D6124-06 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:
Shijiazhuang Junfei Plastic Products Co., Ltd.'s Powder Free (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.
{2}------------------------------------------------
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 stylized eagle with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
FEB 2 8 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Shijiazhuang Junfei Plastic Products Company Limited C/O Ms. Kathy Liu Gloveco, Incorporated 3973 Schaefer Avenue Chino, California 91710
Re: K063471
Trade/Device Name: Powder Free (White) Vinyl Patient Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: February 15, 2007 Received: February 15, 2007
Dear Ms. Kathy 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.
{3}------------------------------------------------
Page 2 - Ms. Kathy 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 complics 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,
Susan Junne
Chi-Li, 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
{4}------------------------------------------------
Attachment A
INDICATION FOR USE
510 (k) NUMBER (IF KNOW): APPLICANT: DEVICE NAME:
K063471 Shijiazhuang Junfei Plastic Prodcuts Co., Ltd. Powder Free (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
(Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Image /page/4/Picture/10 description: The image shows the text "Concurrent of CDRH, Office of Device Evaluation (ODE)" at the top. Below the text is a signature. The signature is illegible.
§ 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.