(173 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.
The provided text describes a 510(k) summary for "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)". This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving performance against acceptance criteria in the typical sense of AI/software device evaluation.
Therefore, many of the requested points related to AI/software device studies (like sample size for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, training sets, etc.) are not applicable to this type of medical device submission. The device is a physical product (gloves), not a software or AI tool.
However, I can extract the relevant acceptance criteria and reported performance based on the information provided, which refers to conformance with ASTM standards.
Here's the breakdown of the information as it applies to this specific submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Test | Acceptance Criteria (from ASTM standards and FDA) | Reported Device Performance (by manufacturer) | Result of Comparison |
|---|---|---|---|
| Device Description & Specifications | Meet all current specifications listed under ASTM Specification D5250 (If vinyl) | Meets ASTM D5250 | Substantially equivalent |
| Material | If the glove is made of a polymer or other type of material, identify the material. | PVC | Substantially equivalent |
| Dusting or Donning Powder / Lubricant | If a donning lubricant is used, state the composition and include biocompatibility data for the lubricant; also state name, manufacturer, and address. (For "powder-free" gloves, meet residual powder limits per ASTM D6124). | PU (Polyurethane) as surface coating agent. (The document implies it is powder-free, aligned with the device name and ASTM D6124 conformance) | Substantially equivalent |
| Product Specifications | Certify that finished "powder-free" gloves meet ASTM D5250. | Meets ASTM D5250 | Substantially equivalent |
| Performance Data (Holes Detection) | Meet ASTM D5151 (Detection of Holes in Medical Gloves) | Meets ASTM D5151 | Substantially equivalent |
| Performance Data (Residual Powder) | Meet ASTM D6124 (Residual Powder on Medical Gloves) | Meets ASTM D6124 | Substantially equivalent |
| Biocompatibility | Skin Irritation: Dermal and Sensitization studies per ISO 10993-10 | SKIN IRRITATION DERMAL and SENSITIZATION STUDIES Meets ISO 10993-10 | Substantially equivalent |
| Water Leak Test on Pinhole AQL | Meet FDA requirements for AQL (Implicitly covered by ASTM D5151 for holes detection) | The conclusion states: "Powder Free Vinyl Patient Examination Gloves meet the ASTM standard or equivalent standard and FDA requirements for waterleak test on pinhole AQL..." (specific AQL not stated in table, but overall claim made) | - |
| Labeling | Requirements for labeling (e.g., "Powder-Free", "Patient Examination Glove", "Single Use Only", "Manufactured For:", "Lot") | Labeling includes: -Powder-Free -Patient Examination Glove -Single Use Only - Manufactured For: - Lot | Substantially equivalent |
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria is not described as a single, centralized study in the document. Instead, it refers to the device's conformance with recognized consensus standards (ASTM D5250-06, ASTM D6124-06, ASTM D5151, and ISO 10993-10) and FDA requirements (specifically 21 CFR 800.20 for water leak test on pinhole AQL).
The manufacturer asserts that their "Powder free vinyl patient examination gloves, Clear(non-colored) meet requirements per ASTM D5250-06, per ASTM D6124-06, per 21 CFR 800.20 and ISO10993-10." This implies that the device successfully passed testing according to the methodologies outlined in these standards.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated in the summary. For physical products tested against ASTM standards, the sample sizes are typically defined within the specific standard's test methods (e.g., for AQL testing for holes, specific sample plans are used).
- Data Provenance: Not explicitly stated beyond "nonclinical submitted". Given the submitter's address in China, it's presumed the testing was conducted in China. It is a retrospective evaluation against established standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not Applicable. This is a physical device submission. Ground truth in the context of expert consensus for AI models is not relevant here. Conformance is determined by physical and chemical testing against objective standards.
4. Adjudication Method for the Test Set:
- Not Applicable. As per point 3, this is a physical device tested against standards; an adjudication method in the context of expert review is not relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No, Not Applicable. MRMC studies are for evaluating diagnostic performance of imaging systems or AI software. This is a physical glove.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- No, Not Applicable. This is a physical device.
7. The Type of Ground Truth Used:
- For this device, "ground truth" equates to the objective measurements and results obtained from testing the gloves against the criteria and methodologies defined in the referenced ASTM standards (D5250, D5151, D6124) and ISO standard (10993-10), as well as FDA regulations for AQL. These are direct physical properties and performance characteristics.
8. The Sample Size for the Training Set:
- Not Applicable. This is a physical device; there is no "training set" in the context of an AI/software algorithm.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. As per point 8.
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510(k) Summarv
"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."
SEP 19 2012
"The assigned 510(k) number is: K120968 8 . " (applicant leave blank)
Premarket Notification J510(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 : | TANGSHAN ZHONGHONG PULIN PLASTIC CO.,LTD. |
|---|---|
| Submitter's address : | NDUSTRIAL ZONE, PACHIGANG, LUANNAN, TANGSHAN, HEBEI, 063502, CHINA |
| Phone number : | (86) 315-4169201 |
| Fax number : | (86) 315-4168700 |
| Name of contact person: | Mr. Zhang Liang |
| Date the summary was prepared: | Aug.20th, 2012 |
-((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 GlovesOther clients private labeling |
| 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.
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.
Page 1 /3 (rev.02)
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Device Intended Use: powder free vinyl patient examination glove, 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 & | Predicate Device | Medical Glove | Subject Device | Result of |
|---|---|---|---|---|
| Description | GuidanceManual(1661) | Comparison | ||
| Company | Shijiazhuang Fuguan | TANGSHAN | - | |
| Plastic Products Co., | ZHONGHONG | |||
| Ltd | PULIN PLASTIC | |||
| CO.,LTD. | ||||
| Product name | FUGUAN | Powder Free Vinyl | ﺴ | |
| (Brand)Powder-Free | Patient Examination | |||
| Vinyl Patient | Gloves | |||
| Examination Gloves,K032908 . | Other clients privatelabeling | |||
| Intend for use | Powder free vinyl | Powder-Free | Powder-Free vinyl | Substantially |
| patient examination | Examination Gloves: | patient examination | equivalent | |
| glove is a disposable | A powder-free patient | gloves is a | ||
| device intended for | examination glove is | disposable device | ||
| medical purposes that | a disposable device | intended for medical | ||
| is worn on the | intended for medical | purposes that is | ||
| examiner's hand or | purposes that is worn | worn on the | ||
| finger to prevent | on the examiner's | examiner's hand or | ||
| contamination | hand or finger to | finger to prevent | ||
| between patient and | prevent | contamination | ||
| examiner. | contamination | between patient and | ||
| between patient and | examiner. | |||
| examiner. | ||||
| Device | Meets ASTM D5250 | If vinyl: | Meets ASTM D5250 | Substantially |
| Description and | Do the vinyl | equivalent | ||
| Specifications | examination gloves | |||
| meet all the current | ||||
| specifications listed | ||||
| under ASTMSpecification D5250 | ||||
| or an equivalent | ||||
| consensus standard? | ||||
| Compare all | PVC | If the glove is made | PVC | Substantially |
| materials used | of a polymer or other | equivalent | ||
| to fabricate the | type of material. | |||
| devices | identify the material. | |||
| Dusting or | PU | If a donning lubricant | PU | Substantially |
| Donning | is used, state the | equivalent | ||
| Powder: | composition and | |||
| include | ||||
| biocompatibility data | ||||
| for the lubricant in an | ||||
| identified attachment; | ||||
| also state the name, | ||||
| manufacturer, and | ||||
| address below | ||||
| PU | Lubricant | Surface Coating | Substantially | |
| Generic Name/ | Agent | equivalent | ||
| LubricantBrand Name | ||||
| Compareproductspecifications | Meets ASTM D5250 | We recommend youcertify that yourfinished "powder-free" gloves meet the | Meets ASTM D5250 | Substantiallyequivalent |
| Compareperformancedata supportingsubstantialequivalence | MeetsASTM D5151ASTM D5250ASTM D6124 | At this time FDArecognizes thefollowing standards:Patient ExaminationGloves(PVC)ASTMD5151(Detection ofHoles in MedicalGloves)ASTMD6124(ResidualPowder on MedicalGloves)ASTMD5250(Poly(vinylchloride) Gloves) | MeetsASTM D5151ASTM D5250ASTM D6124 | Substantiallyequivalent |
| Single PatientUse | Single Patient Use | Single Patient Use | Single Patient Use | Substantiallyequivalent |
| Biocompatibility | SKIN IRRITATIONDERMAL andSENSITIZATIONSTUDIES Meets ISO10993-10 | SKIN IRRITATIONDERMAL andSENSITIZATIONSTUDIESISO 10993-10 | SKIN IRRITATIONDERMAL andSENSITIZATIONSTUDIES MeetsISO 10993-10 | Substantiallyequivalent |
| Labeling for thelegallymarketeddevice to whichsubstantialequivalence isclaimed | -Powder-Free-Patient ExaminationGlove-Single Use Only- Manufactured For:- Lot | Chapter 4 | -Powder-Free-PatientExamination Glove-Single Use Only- Manufactured For:- Lot | Substantiallyequivalent |
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[(b)(1)] A_brief discussion_of the nonclinical submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalence .
Powder free vinyl patient examination gloves , Clear(non-colored) meet requirements per ASTM D5250-06, per ASTM D6124-06, per 21 CFR 800.20 and ISO10993-10.
[(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 and clinical 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 .
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the agency's mission. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Tangshan Zhonghong Pulin Plastic Company, Limited Mr. Chu Xiaoan Room 1606 Building 1, Jianxiang Yuan No.209 Bei SI Huan Zhong Road Haidian District Beijing, 100083, P.R. China
SEP
19
2012
Re: K120968
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: September 6, 2012
Received: September 13, 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 Federal 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 vours,
for
B. Smith m.d.
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: TANGSHAN ZHONGHONG PULIN PLASTIC CO.,LTD.
510(k) Number (if known): *
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) | X |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ln cut
Sign Off)
of Amesthesiology, General Hospital
of Amesthesiology, General Dovices Infection Control, Den
510(k) Number: R120
§ 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.