(71 days)
Powder free vinyl 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.
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011).
The provided text describes the 510(k) summary for "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)" manufactured by Geenli Plastic Co., Ltd. It outlines the device's characteristics and its substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The device performance is compared against ASTM standards and FDA requirements. The text explicitly states that the Subject Device (Geenli's gloves) meets these standards.
| Acceptance Criteria (Standard/Test) | Reference/Requirement | Reported Device Performance (Subject Device) |
|---|---|---|
| Device Specifications (General) | ASTM D5250 (or equivalent consensus standard for vinyl examination gloves) | Meets ASTM D5250 |
| Detection of Holes | ASTM D5151 (Detection of Holes in Medical Gloves) | Meets ASTM D5151 |
| Residual Powder | ASTM D6124 (Residual Powder on Medical Gloves) | Meets ASTM D6124 |
| Biocompatibility (Skin Irritation) | ISO 10993-10: 2006 third edition 2010-08-01 (SKIN IRRITATION DERMAL and SENSITIZATION STUDIES) | Meets ISO 10993-10 |
| Biocompatibility (Water Leak Test) | 21 CFR 800.20 (Waterleak test on pinhole AQL) | Meets 21 CFR 800.20 |
| Intended Use | Disposable device for medical purposes, worn on hand/finger to prevent contamination between patient and examiner. | Substantially equivalent to predicate |
| Material | PVC | PVC |
| Dusting/Donning Powder | PU (identified as lubricant with biocompatibility data) | PU (Surface Coating Agent) |
| Single Patient Use | Single Patient Use | Single Patient Use |
| Labeling | -Powder-Free, -Patient Examination Glove | -Powder-Free, -Patient Examination Glove |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the precise sample size used for the non-clinical tests (e.g., how many gloves were tested for holes, powder residue, or biocompatibility). It simply states that the device "meets requirements per ASTM D5250-06(Reaffirmation 2011), per ASTM D6124-06(Reaffirmation 2011), per 21 CFR 800.20 and ISO10993-10: 2006 third edition 2010-08-01." These standards themselves would typically define the sampling plans and acceptable quality levels (AQLs) for testing.
- Data Provenance: The document does not explicitly state the country of origin for the test data, nor whether the data was retrospective or prospective. It is implied to be prospective testing conducted by the manufacturer to demonstrate compliance with standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This section is not applicable as the device is a medical glove, and the acceptance criteria are based on objective physical, chemical, and biological performance standards (e.g., hole detection, tensile strength, biocompatibility), not on expert subjective interpretation or ground truth derived from expert consensus.
4. Adjudication Method for the Test Set
This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., medical imaging) where there might be disagreement among reviewers on a specific finding. The tests for these gloves are objective physical and chemical tests against defined standards.
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 relevant for diagnostic devices that involve human readers interpreting results (e.g., radiologists reading images). This device is a medical glove, whose performance is assessed through objective criteria.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. A standalone performance evaluation (without human-in-the-loop) is relevant for AI algorithms or diagnostic systems. This device is a physical medical glove.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is based on objective, standardized test results against established national and international standards. Specifically:
- Physical properties (e.g., integrity, dimensions) are evaluated against ASTM D5250 and D5151.
- Chemical properties (e.g., powder residue) are evaluated against ASTM D6124.
- Biocompatibility is evaluated against ISO 10993-10.
- Manufacturing quality and AQL for pinholes are evaluated against 21 CFR 800.20.
There is no "expert consensus," "pathology," or "outcomes data" in the typical sense of a diagnostic or therapeutic device. The ground truth is the measured compliance with the specified performance standards.
8. The Sample Size for the Training Set
This section is not applicable. The concept of a "training set" refers to data used to train machine learning models. This device is a physical medical glove and does not involve an algorithm or AI that requires training data.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the same reasons as point 8.
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510(K)Summary
"This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92."
"The assigned 510(k) number is: 15122 89 3" (applicant leave blank)
Premarket Notification [510(k)] Summary
[{a)(1)]. The summary contains on the first page, preferably on your letterhead paper, the submitter's name, address, phone and fax numbers, name of contact person, and date the summary was prepared :
| Submitter's name : | Geenli Plastic Co., Ltd. |
|---|---|
| Submitter's address : | #88, Xinshizhong Rd. Shijiazhang, 050000 China |
| Phone number : | (86) 0311-67699886 |
| Fax number : | (86) 0311-67699916 |
| Name of contact person: | Mr. Luo Fei |
| Date the summary was prepared: | Oct. 29, 12 |
[(a)(2)]. The name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known
| Device Name: | Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) |
|---|---|
| Proprietary/Trade name: | Powder Free Vinyl Patient Examination Gloves |
| Common Name: | Patient examination glove |
| Classification Name: | Patient examination glove |
| Device Classification: | I |
| Regulation Number: | 21 CFR 880.6250 |
| Panel: | General Hospital (80) |
| Product Code: | LYZ |
[(a)(3)]. An identification of the legally marketed device to which your firm is claiming substantial equivalence .
Class I* Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011).
Predicate device : FUGUAN (Brand) Powder-Free Vinyl Patient Examination Gloves, Shijiazhuang Fuguan Plastic Products Co., Ltd.. K032908 .
[(a)(4)] A description of the device
Device Description: Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011).
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[(a)(5)] The summary describes the intended use of the device
Device Intended Use: Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)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)(6)] A summary of the technological characteristics of new device compared to the predicate device.
The powder free vinyl patient examination gloves, non sterile are summarized with the following technological characteristics compared to ASTM or equivalent standard.
| Features &Description | Predicate Device | Medical GloveGuidanceManual(1661) | Subject Device | Result ofComparison | |
|---|---|---|---|---|---|
| Company | ShijiazhuangFuguan PlasticProducts Co., Ltd..K032908 . | Geenli Plastic Co.,Ltd. | -- | ||
| Product name | Powder Free VinylPatientExaminationGloves, Clear(non-colored) | Powder Free VinylPatientExaminationGloves, Clear (non-colored) | -- | ||
| Intend for use | Powder Free VinylPatientExaminationGloves, Clear(non-colored)is adisposable deviceintended formedical purposesthat is worn on theexaminer's hand orfinger to preventcontaminationbetween patientand examiner. | Powder-FreeExaminationGloves:A powder-freepatientexaminationglove is adisposabledevice intendedfor medicalpurposes that isworn on theexaminer's handor finger topreventcontaminationbetween patientand examiner. | Powder Free VinylPatientExaminationGloves, Clear (non-colored) is adisposable deviceintended formedical purposesthat is worn on theexaminer's hand orfinger to preventcontaminationbetween patient andexaminer. | Substantiallyequivalent | |
| DeviceDescription andSpecifications | Meets ASTMD5250 | If vinyl:Do the vinylexaminationgloves meet allthe currentspecificationslisted underASTMSpecificationD5250 or anequivalentconsensusstandard? | Meets ASTMD5250 | Substantiallyequivalent | |
| Compare allmaterials used tofabricate the | PVC | If the glove ismade of apolymer or other | PVC | Substantiallyequivalent | |
| devices | type of material.identify thematerial. | ||||
| Dusting orDonning Powder: | PU | If a donninglubricant is used,state thecomposition andincludebiocompatibilitydata for thelubricant in anidentifiedattachment; alsostate the name,manufacturer,and addressbelow | PU | Substantiallyequivalent | |
| Dusting orDonning Powder:name | PU | LubricantGeneric Name/LubricantBrand Name | Surface CoatingAgent | Substantiallyequivalent | |
| Compare productspecifications | Meets ASTMD5250 | We recommendyou certify thatyour finished"powder-free"gloves meet thefollowing:ASTM D 5250standard or anequivalentstandard forvinyl | Meets ASTMD5250 | Substantiallyequivalent | |
| Compareperformance datasupportingsubstantialequivalence | MeetsASTM D5151ASTM D5250ASTM D6124 | At this timeFDA recognizesthe followingstandards:PatientExaminationGloves(PVC)ASTMD5151(Detectionof Holes inMedical Gloves)ASTMD6124(ResidualPowder onMedical Gloves)ASTMD5250(Poly(vinyl chloride)Gloves) | MeetsASTM D5151ASTM D5250ASTM D6124 | Substantiallyequivalent | |
| Single Patient Use | Single Patient Use | Single PatientUse | Single Patient Use | Substantiallyequivalent | |
| Biocompatibility | SKINIRRITATIONDERMAL andSENSITIZATIONSTUDIES MeetsISO 10993-10 | SKINIRRITATIONDERMAL andSENSITIZATION STUDIESISO 10993-10Chapter 4 | SKINIRRITATIONDERMAL andSENSITIZATIONSTUDIES MeetsISO 10993-10 | Substantiallyequivalent | |
| Labeling for thelegally marketeddevice to which | -Powder-Free-PatientExamination Glove | -Powder-Free-PatientExamination Glove | Substantiallyequivalent |
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| equivalence is | - Manufactured | - Manufactured | |
|---|---|---|---|
| claimed. | For: | For: | |
| - Lot | - Lot |
[(b)(1)] A brief discussion of the non-clinical testing data that was submitted, referenced or relied on to demonstrate that the Subject Device is safe and effective, and whose performance meets the requirements of its pre-defined acceptance criteria and intended uses.
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)meet requirements per ASTM D5250-06(Reaffirmation 2011), per ASTM D6124-06(Reaffirmation 2011), per 21 CFR 800.20 and ISO10993-10: 2006 third edition 2010-08-01., it is safe and effective, and it's performance meets the requirements of its pre-defined acceptance criteria and intended uses. [(b)(2)] A brief discussion of the clinical submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalence .
Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.
[(b)(3)] The conclusions drawn from the nonclinical tests that demonstrate that the device is as safe,as effective, and performed as well or better than the legally marketed device identified in (a)(3).
It can be concluded that the Powder Free Vinyl Patient Examination Gloves meet the ASTM standard or equivalent standard and FDA requirements for waterleak test on pinhole AQL., meet labeling claims . It is as safe, as effective, and performed as well the legally marketed device identified in (a)(3).
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird-like figure.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-002
November 30, 2012
Geenli Plastic Company, Limited C/O Mr. Chu Xiaoan Room 1606 Building 1, Jianxiang Yuan No. 209 Bei Si Huan Zhong Road, Haidian District Beijing, China 100083
Re: K122893
Trade/Device Name: Powder Free Vinyl Patient Examination Gloves,
Clear (Non-Colored) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: October 29, 2012 Received: November 1, 2012
Dear Mr. Xiaoan:
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 Eederal Register.
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Page 2 - Mr. Xiaoan
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 device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Anthong Dr. m
Anthony D. Watson, B.S., M.S., M.B.A. 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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INDICATIONS FOR USE
Applicant: GEENLI PLASTIC CO., LTD
510(k) Number (if known): * K12コ 893
Device Name: Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
Indications For Use:
Powder free vinyl 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.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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Ivision of Anesthestology, General Hospit:
Intellion Control, Dental Devices Sivision Sign-Off (Division of Anesthestology of
510(k) Number: J
§ 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.