(107 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 Glove, 80 LYZ, and meets all requirements of ASTM standard D-5250-00E4
The provided text describes the acceptance criteria and the study conducted for the "Shijiazhuang Hongxiang Plastic Products Co., Ltd. Vinyl Co-Polymer Powder Free Examination Gloves, Blue Color." This is a Class I medical device (patient examination glove). The evaluation focuses on demonstrating substantial equivalence to a predicate device, as per FDA 510(k) requirements.
Here's an analysis of the provided information in the requested format:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standard / Test) | Reported Device Performance |
|---|---|
| Physical and Dimensions Testing | Met requirements based on ASTM D-5250-00E4 (Inspection level S-2, AQL 4.0) |
| Integrity (Pinhole Test) | Met FDA 1000 ml. Water Fill Test requirements based on ASTM D-5151-99 (AQL 2.5, inspiration level G-1) |
| Biocompatibility (Irritation) | No primary skin irritant reactions in Primary Skin Irritation testing |
| Biocompatibility (Sensitization) | No sensitization reactions in Skin Sensitization testing |
| Residual Powder | Met "powder-free" claims (contains no more than 2 mg powder per glove) based on ASTM D-6124-06 |
2. Sample Size Used for the Test Set and Data Provenance:
- Physical and Dimensions Testing: Inspection level S-2, AQL 4.0. The specific number of gloves tested is not provided, but AQL (Acceptable Quality Limit) indicates the maximum acceptable percentage of defective items.
- Pinhole Test (Water Fill Test): AQL 2.5, inspection level G-1. The specific number of gloves tested is not provided, but AQL indicates the maximum acceptable percentage of defective items.
- Primary Skin Irritation and Skin Sensitization Testing: The sample size for these biological tests is not specified in the document.
- Residual Powder Test: The sample size is not specified in the document.
- Data Provenance: The origin of the data is from testing performed by Shijiazhuang Hongxiang Plastic Products Co., Ltd. in China. The study appears to be prospective as it involves new testing of the device for 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 Class I examination glove, and the evaluation does not involve diagnostic interpretation that would require expert human readers to establish ground truth from medical images or clinical observations. The ground truth is objective measurements against established ASTM standards and FDA requirements.
4. Adjudication Method for the Test Set:
- Not applicable. As the tests are objective measurements against defined physical, chemical, and biological standards (e.g., AQL, mg of powder, presence/absence of irritation), there is no adjudication process involving multiple human reviewers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. An MRMC study is not relevant for this type of device. Such studies are typically conducted for diagnostic imaging devices or algorithms where human interpretation is a key component.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in essence. The testing performed (physical, dimensional, pinhole, biocompatibility, residual powder) is equivalent to a "standalone" evaluation of the device's inherent properties without human interaction or interpretation as part of its primary function. The device itself is not an algorithm, but its performance is measured directly.
7. The Type of Ground Truth Used:
- Objective Standards and Measurement: The ground truth is established by:
- ASTM Standards: D-5250-00E4 (physical and dimensions), D-5151-99 (pinhole/water fill), D-6124-06 (residual powder).
- FDA Requirements: Specific pinhole requirements and biocompatibility expectations.
- Defined Limits: E.g., no more than 2 mg powder per glove for "powder-free" claim.
- Direct Biological Observation: For skin irritation and sensitization tests.
8. The Sample Size for the Training Set:
- Not applicable. This device is not an AI/ML algorithm or a diagnostic tool that requires a "training set." The testing is for a physical medical product.
9. How the Ground Truth for the Training Set was Established:
- Not applicable. There is no training set for this type of device.
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JUL 1 3 2007
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: KO 90 852
l . Submitter's Identification:
Mr. Zhanmin Lu Shijiazhuang Hongxiang Plastic Products Co., Ltd. New high technologies industrial zone, Luquan city, Hebei, China 050200
Date Summary Prepared: Dec 30, 2006
2. Name of the Device:
Shijiazhuang Hongxiang Plastic Products Co., Ltd. Vinyl Co-Polymer Powder Free Examination Gloves, Blue Color
3. Predicate Device Information:
Grand Work Plastic Products Co., Ltd. Vinyl Co-Polymer Powder Free Examination Gloves, Blue Color (K061562)
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 Glove, 80 LYZ, and meets all requirements of ASTM standard D-5250-00E4
equirements of ASTM Standard D-5230-00
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 Hongxiang Plastic Products Co., Ltd.'s Vinyl Co-Polymer Powder Free Examination Gloves (Blue Color) is substantially equivalent in safety and effectiveness to the Grand Work Plastic Products Co., Ltd.'s Vinyl Co-Polymer Powder Free Examination Gloves (Blue Color)
7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as Follows:
The standards used for Shijiazhuang Hongxiang Plastic Products Co., Ltd.'s glove product are bassed on ASTM D-5250-00€4. 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 based on ASTM D-5151-99 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.
There are no special labeling claims and we do not claim our gloves as hypoallergenic on our labels.
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. Discussion of Clinical Tests Performed:
Not Applicable - There is no hypoallergenic Claim.
9. Conclusions:
Shijiazhuang Hongxiang Plastic Products Co., Ltd.'s Vinyl Co-Polymer Powder Free Examination Gloves (Blue Color) conform fully to ASTM D-5250-0054 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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ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 3 2007
Shijiazhuang Hongxiang Plastic Products Company Limited C/O Ms. Kathy Liu Official Correspondent Gloveco, Incorporated 3973 Schaefer Avenue
Re: K070852
Chino, California 91710
Trade/Device Name: Vinyl Co-Polymer Powder Free Exam Gloves, Blue Color Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: June 22, 2007 Received: June 25, 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 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Clues
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
Page 1 of 1
510(K) NUMBER (IF UNKNOW): KO70852 Shijiazhuang Hongxiang Plastic Products Co., Ltd. APPLICANT: Vinyl Co-Polymer Powder Free Exam Gloves, Blue Color DEVICE NAME:
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-Count 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) |
|---|
| (Division Sign-Off) |
| Division of Anesthesiology, General Hospital |
| Infection Control, Dental Devices |
510(k) Number: K070852
§ 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.