(26 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.
This document describes the testing and acceptance criteria for Shijiazhuang Lianhe Shunda Plastic Products Co., Ltd.'s Powder Free (Yellow) Vinyl Patient Examination Gloves.
Here is the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Criteria Category | Specific Test/Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Physical Dimensions | ASTM D-5250-00E4 | Meets all requirements (specifics not detailed in document but implied by standard) | Meets all requirements |
| Integrity (Pinhole) | FDA 1000 ml. Water Fill Test | AQL 2.5, Inspection Level I | Meets these 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 Residue | Residual Powder Test (based on ASTM D-6124-06) | No more than 2 mg powder per glove | Meets "powder-free" claims (i.e., less than 2 mg powder per glove) |
| Quality System | General/Manufacturing | Inspection Level S-2, AQL 4.0 | Meets these requirements |
2. Sample Size Used for the Test Set and Data Provenance
- Pinhole (Water Fill Test): "samplings of AQL 2.5, inspection level I" - The exact sample size is not explicitly stated, but it would be determined by the AQL and inspection level, referencing ISO 2859-1 or a similar standard.
- Physical Dimensions & Quality System: "Inspection level S-2, AQL 4.0" - Similar to the pinhole test, the exact sample size is not explicitly stated.
- Biocompatibility & Residual Powder: Sample sizes were not specified in the provided document.
- Data Provenance: The tests were conducted by the manufacturer, Shijiazhuang Lianhe Shunda Plastic Products Co., Ltd., in China. The data would be considered retrospective as it was conducted on finished products for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is a medical glove, and its performance is evaluated against engineering standards and material properties, not through expert human interpretation or diagnosis.
4. Adjudication Method for the Test Set
Not applicable. The tests are objective measurements against established standards (e.g., water fill for pinholes, chemical analysis for powder, physical measurements for dimensions). No human adjudication of differing interpretations is required.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices that involve human interpretation of results (e.g., radiology images), not for a medical device like an examination glove.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the testing described is effectively standalone performance. The device's characteristics (physical properties, absence of pinholes, biocompatibility, powder residue) were measured directly without human intervention or interpretation that would alter the test outcome.
7. The Type of Ground Truth Used
The ground truth used for this device is based on:
- Industry Standards: Adherence to ASTM standard D-5250-00E4 for physical and dimensional characteristics, and ASTM D-6124-06 for residual powder.
- Regulatory Requirements: Adherence to FDA's 1000 ml. Water Fill Test for pinholes, and biocompatibility testing requirements.
- Objective Measurements: These standards and requirements define objective, measurable performance criteria.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI-based device, so there is no "training set." The product is manufactured and then tested for compliance.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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JAN 2 9 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: _ K 0700444
l . Submitter's Identification:
Mr. Li Quanfu Shijiazhuang Lianhe Shunda Plastic Products Co., Ltd. Nanwuhui Village, Yuanshi County Shijiazhuang, Hebei, China 051130
Date Summary Prepared: September 20, 2006
2. Name of the Device:
Shijiazhuang Lianhe Shunda Plastic Products Co., Ltd. Powder Free (Yellow) 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-5250-00E4.
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.
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6. Comparison to Predicate Devices:
Shijiazhuang Lianhe Shunda Plastic Products Co., Ltd.'s Powder Free (Yellow) Viny) 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 Shijiazhuang Lianhe Shunda Plastic Products Co., Ltd.'s glove production are based on ASTM-D-5250-00 E4. 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:
Shijiazhuang Lianhe Shunda Plastic Products Co., Ltd.'s Powder Free (Yellow) 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.
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Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 9 2007
Shijiazhuang Lianhe Shunda Plastic Products Co., Ltd. C/O Ms. Kathy Liu Gloveco, Incorporated 3973 Schaefer Avenue Chino, California 91710
Re: K070044
Trade/Device Name: Powder Free (Yellow) Vinyl Patient Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: December 28, 2006 Received: January 3, 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.
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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 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.
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
510 (k) NUMBER (if KNOW): ΚΟΥ ΟΟ 44 APPLICANT: DEVICE NAME:
Shijiazhuang Lianhe Shunda Plastic Products Co., Ltd. Powder Free (Yellow) Vinyl Patient Examination Glove.
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)
Shule A. Murphy, bo
I Ana Jircelalogy, Ganeral Hospil.
Julia. Lonal Dovices
§ 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.