(36 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-5250-00E4.
This 510(k) submission describes the Super Safe Plastic Products Co., Ltd. Powder Free Vinyl Patient Examination Gloves, White. The submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study of the device's performance against specific acceptance criteria. Therefore, several of the requested sections (e.g., details on training set, experts, MRMC studies) are not applicable or cannot be extracted from the provided text.
Here is an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Physical and Dimensions Testing: Based on ASTM-D-5250-00E4 standard. | Meets all requirements for physical and dimensions testing. (Inspection level S-2, AQL 4.0) |
| Pinhole / Water Leak Test: FDA 1000 ml. Water Fill Test. | Meets requirements. (Samplings of AQL 2.5, inspection level I) |
| Primary Skin Irritation: | No primary skin irritant reactions. |
| Skin Sensitization (Allergic Contact Dermatitis): | No sensitization reactions. |
| Residual Powder Test: Based on ASTM D6124-06 for Starch. | Contains no more than 2 mg powder per glove, meeting "powder-free" claims. |
| Biocompatibility: | Meets biocompatibility requirements. (General statement, specific criteria not detailed) |
| Labeling Compliance: Does not claim hypoallergenic. | No special labeling claims; does not claim hypoallergenic. |
| Compliance with ASTM D-5250-00E4: | Conforms fully to ASTM D-5250-00E4 standard. |
| Compliance with 21 CFR references: | Conforms fully to applicable 21 CFR references. |
2. Sample size used for the test set and the data provenance
- Physical and Dimensions Testing: Inspection level S-2, AQL 4.0. The specific sample size for a given lot is not provided but would be determined by the AQL (Acceptable Quality Limit) and inspection level. This is a factory quality control measure, so the data provenance is from the manufacturer's internal testing in China (Shijiazhuang, Hebei, China). This is retrospective testing of manufactured products.
- Pinhole / Water Fill Test: Samplings of AQL 2.5, inspection level I. Similar to above, the specific sample size for a given lot is not provided. Data provenance is from the manufacturer's internal testing in China, retrospective.
- Primary Skin Irritation and Skin Sensitization: The document states that testing was conducted but does not specify the sample size or the data provenance beyond "with results showing." It is typically done on human subjects or animal models as per relevant ISO standards.
- Residual Powder Test: Not specified beyond "at finished inspection."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a Class I medical device (patient examination gloves) and the testing described is primarily for engineering performance and biocompatibility, not for diagnostic or therapeutic efficacy requiring expert ground truth for interpretation.
4. Adjudication method for the test set
Not applicable. The tests are objective measurements against established standards (ASTM, FDA) for physical properties, chemical residue, and biological reactivity, not subjective interpretations requiring 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
Not applicable. This device is a physical barrier (glove), not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm.
7. The type of ground truth used
- Physical and Dimensions Testing: The ground truth is defined by the specifications in ASTM D-5250-00E4.
- Pinhole / Water Leak Test: The ground truth is defined by the FDA 1000 ml. Water Fill Test requirements.
- Primary Skin Irritation and Skin Sensitization: The ground truth is established by standard toxicological assessment protocols, typically involving expert interpretation of skin reactions.
- Residual Powder Test: The ground truth is defined by the maximum allowable powder content (2 mg/glove) as per ASTM D6124-06.
8. The sample size for the training set
Not applicable. This is a medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
{0}------------------------------------------------
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: K070043
1. Submitter's Identification:
Mr. Lu Wenxin Super Safe Plastic Products Co., Ltd. Meng Er Village, Pingshan County Shijiazhuang, Hebei, China 050401
Date Summary Prepared: September 20, 2006
2. Name of the Device:
Super Safe Plastic Products Co., Ltd. Powder Free Vinyl Patient Examination Gloves. White
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 disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
{1}------------------------------------------------
6. Comparison to Predicate Devices:
Super Safe Plastic Products Co., Ltd.'s Powder Free Vinyl Patient Examination Gloves, White 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 Super Safe Plastic Products Co., Ltd.'s glove production are based on ASTM-D-5250-00E4. 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 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:
Super Safe Plastic Products Co., Ltd.'s Powder Free Vinyl Patient Examination Gloves, White conform fully to ASTM D-5250-00E 4 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}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Super Safe Plastic Products Company, Limited C/O Ms. Kathy Liu Official Correspondent Gloveco, Incorporated 3973 Schaefer Avenue FEB Chino, California 91710
Re: K070043
Trade/Device Name: Powder Free Vinyl Patient Examination Gloves, White Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: December 28, 2006 Received: January 3, 2007
8 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.
{3}------------------------------------------------
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Susan Dunne
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
{4}------------------------------------------------
Attachment A
INDICATION FOR USE
510 (k) NUMBER (IF KNOW): APPLICANT: DEVICE NAME:
Super Safe Plastic Products Co., Ltd. Powder Free Vinyl Patient Examination Gloves, White.
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.)
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.