(214 days)
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or fingers to prevent contamination between patient and examiner.
Subject device: Vinyl Exam Gloves, Powder Free, Clear
Device Class: Class I
Regulation number: 21 CFR 880.6250
Product code: LYZ
Length: 230 mm min
Width: 94 mm min
Palm Thickness: 0.09 mm min
Fingertip Thickness: 0.085 mm min
Tensile Strength (Mpa) Before aging 16.96Mpa average After aging 14.92Mpa average
Ultimate Elongations Before aging 519% average After aging 480% average
Device functions: As a barrier, the subject device prevents contamination between patient and examiner
This document is a 510(k) Premarket Notification from the FDA regarding "Vinyl Exam Gloves, Powder Free, Clear". It's a regulatory submission for a medical device and does not describe an AI/ML powered device or a study related to AI/ML.
Therefore, I cannot provide the requested information about acceptance criteria and studies for an AI device. The document is about physical properties and biocompatibility of examination gloves, not an AI system.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 19, 2016
Zibo Hongchin Plastic and Rubber Co., Ltd % Ms. Sophie Hao Official Correspondent Basic Medical Industries, Inc. 805 Barrington Ave Ontario, CA 91764
Re: K161390
Trade/Device Name: Vinyl Exam Gloves, Powder Free, Clear Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: November 2, 2016 Received: November 10, 2016
Dear Ms. Hao:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael J. Ryan -S
for Tina Kiang, PhD Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control. and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) KIJ1390
Device Name
Vihyl Exam Gloves, Powder Free, Clear
Indications for Use (Describe)
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or fingers to prevent contamination between patient and examiner.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
2 Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510 (K) SUMMARY
1. Submitter's Identification:
Zibo Hongchin Plastic and Rubber Co.,Ltd No 17 Yingxiong Rd, Zhangdian District, Zibo Shandong, 255400 China
Date summary prepared: December 8, 2016
2. Name of the Device:
Zibo Hongchin Plastic and Rubber Co.,Ltd Vinyl Exam Gloves, Powder Free, Clear
3. Common name/classification name of the Device: Patient Examination Gloves Device Class: Class I Regulation number: 21 CFR 880.6250 Product code: LYZ
4. Contact Person:
James Ren, Product Manager Phone: # 86-1378989666 Zibo Hongchin Plastic and Rubber Co.,Ltd No 17 Yingxiong Rd, Zhangdian District, Zibo Shandong, 255400 China
Predicate Device Information: ક.
Device name: Vinyl Examination Gloves Powder-Free 510(K) #: K022091 Manufacturer name: Tangshan Zhonghong Pulin Food Products Co., Ltd
6. Device Description:
Subject device: Vinyl Exam Gloves, Powder Free, Clear Device Class: Class I Regulation number: 21 CFR 880.6250 Product code: LYZ Length: 230 mm min Width: 94 mm min Palm Thickness: 0.09 mm min Fingertip Thickness: 0.085 mm min
Tensile Strength (Mpa) Before aging 16.96Mpa average After aging 14.92Mpa average
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Ultimate Elongations Before aging 519% average After aging 480% average
Device functions: As a barrier, the subject device prevents contamination between patient and examiner
7. Indication for Use:
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or fingers to prevent contamination between patient and examiner
8. Comparison to Predicate Devices:
Zibo Hongchin Plastic and Rubber Co., Ltd Vinyl Exam Gloves, Powder Free, Clear are substantially equivalent in safety and effectiveness to the Zhonghong Pulin Food Products Co., Ltd Vinyl Examination Gloves, Powder-Free. (K022091)
| Proposed Device | Predicate Device (K022091) | COMMENTS | |
|---|---|---|---|
| The device | Zibo Hongchin Plastic andRubber Co.,Ltd Vinyl ExamGloves, Powder Free, Clear | Vinyl Examination Gloves,Powder-Free TangshanZhonghong Pulin FoodProducts Co., Ltd | |
| Regulation # | 21 CFR 880.6250 | 21 CFR 880.6250 | Similar |
| Device Class | Class I | Class I | Similar |
| Product Code: | LYZ | LYZ | Similar |
| Indications forUse | A patient examination glove isa disposable device intendedfor medical purposes that isworn upon the examiner'shands or fingers to preventcontamination between patientand examiner | A patient examination gloveis a disposable deviceintended for medicalpurposes that is worn uponthe examiner's hands orfingers to preventcontamination betweenpatient and examiner | Similar |
| Basic Design | Cover the hand and wrist area.Clovers have separate sheathsor openings for each fingerand the thumb. | Cover the hand and wristarea. Clovers have separatesheaths or openings for eachfinger and the thumb. | Similar |
| Device Materials | Poly Vinyl Chloride | Poly Vinyl Chloride | Similar |
| Residual Powder | <2 mg per glove and meet therequirement of ASTM D6124-06. | <2 mg per glove | Similar |
| Length onMedium Size | 230 mm min | 230 mm min | Similar |
| Width of Palm onMedium Size | 94 mm min | 94 mm min | Similar |
| Palm Thickness | 0.09 mm min | 0.09 mm min | Similar |
| FingertipThickness | 0.085 mm min | 0.085 mm min | Similar |
| TensileStrength(Mpa)and UltimateElongationsBefore Aging: | 16.96 average (Tensilestrength)519% average (elongated rate)Meet requirement underASTM D5250-06 | 16.96 average (Tensilestrength)519% average (elongatedrate)Meet requirement underASTM D5250-06 | Similar |
| TensileStrength(Mpa)and UltimateElongations AfterAging: | 14.92 average (Tensilestrength)480% average (elongated rate)Meet requirement underASTM D5250-06 | 14.92 average (Tensilestrength)480% average (elongatedrate)Meet requirement underASTM D5250-06 | Similar |
| Pinhole Results | AQL 2.5, met per ASTMD5151-06 | AQL 2.5 | Similar |
| Primary SkinIrritationPer ISO-10993-10 | Not an irritant under thecondition of study | Not an irritant under thecondition of study | Similar |
| DermalSensitization | Not a sensitizer under thecondition of study | Not a sensitizer under thecondition of study | Similar |
| Labeling | Labels include: Product name;Non-sterile; color; "single useOnly" size, Quantity,ambidextrous, lot number,distributor name, indicationfor use and manufactureraddress. | Labels include: Productname; Non-sterile; color;"single use" size, Quantity,ambidextrous, distributorname, indication for use andmanufacturer address. | Similar |
| Substantiallyequivalentcomparison | Powder-free Vinyl Patient Examination Glove, the subject device in K161390, hassimilar intended use and is substantially equivalent to the predicate device(K022091), |
Table 7-2. Side-by-Side Comparison of Intended Use, Design, Material, Physical, Biocompatibility, and Performance Testing
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K161390
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9. Discussion of Non-Clinical tests performed for Determination of Substantial Equivalence are as follows:
The standards used for Zibo Hongchin Plastic and Rubber Co.,Ltd glove production are based on ASTM-D-5250-06. All testing meets requirements for dimensions, physical properties, barrier properties and powder under ASTM-D-5250-06. Physical property test conducted on gloves meets Inspection Level S-2, AQL 2.5.
The FDA 1000 ml. Water Fill Test was also conducted with samplings of AQL 2.5, Inspection Level I, meeting these requirements.
Biocompatibility test results showing no primary skin irritation or sensitization under the conditions of study.
10. Patient Contact
The glove is available for surface-contacting with less than 24 hours duration.
11. Sterilization
Subject device is non-sterile examination gloves for single use.
12. Discussion of Clinical Tests Performed:
Not Applicable
13. Conclusions:
The Zibo Hongchin Plastic and Rubber Co., Ltd Vinyl Exam Gloves, Powder Free, Clear are substantially equivalent to the predicate Vinyl Powder Free Examination Glove cleared under K022091.
§ 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.