(133 days)
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) is a non-sterile 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 a 510(k) summary for "Powder Free Vinyl Patient Examination Gloves, Clear (Non-colored)" and focuses on demonstrating substantial equivalence to a predicate device. It does not contain information about a study with acceptance criteria in the typical sense for an AI/ML medical device. Instead, it details performance characteristics against established ASTM standards and ISO guidelines for medical gloves.
Here's how to interpret the request in the context of the provided document:
1. A table of acceptance criteria and the reported device performance:
| Feature & Description | Acceptance Criteria (Predicate / ASTM D5250-06 (Reapproved 2011) / ASTM D6124-06 (Reaffirmation 2011) / ASTM D5151-06 (Reapproved 2011) / ISO 10993-10:2002/Amd.1:2006) | Reported Device Performance (Subject Device) |
|---|---|---|
| Product name | Powder Free Vinyl Patient Examination Gloves, Clear (Non-colored) | Powder Free Vinyl Patient Examination Gloves, Clear (Non-colored) |
| Product Code | LYZ | LYZ |
| Size | Small/Medium/Large/X large | Small/Medium/Large/X large |
| Intended Use | Disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. | Disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. |
| Device Description & Specs | Meets ASTM D5250-06 (Reapproved 2011) | Meets ASTM D5250-06 (Reapproved 2011) |
| Dimensions -- Length | ≥230mm min. (ASTM D5250-06 (Reapproved 2011)) | 230mm min for all sizes (Meets ASTM D5250-06 (Reapproved 2011)) |
| Dimensions -- Width | Small 80-90 mm, Medium 90-100mm, Large 100-110mm, X large 110-120 mm (ASTM D5250-06 (Reapproved 2011)) | Small 85-88 mm, Medium 94-97 mm, Large 103-106 mm, X large 113-115 mm (Meets ASTM D5250-06 (Reapproved 2011)) |
| Dimensions -- Thickness | Finger 0.05mm min., Palm 0.08mm min. (ASTM D5250-06 (Reapproved 2011)) | Finger 0.05mm min., Palm 0.08mm min. (Meets ASTM D5250-06 (Reapproved 2011)) |
| Physical Properties | Before aging/after aging Elongation ≥300%, Tensile Strength≥11MPa (ASTM D5250-06 (Reapproved 2011)) | Before aging/after aging Elongation ≥300%, Tensile Strength≥ 11 MPa (Meets ASTM D5250-06 (Reapproved 2011)) |
| Freedom from Pinholes | Meets 21 CFR 800.20, ASTM D5250-06 (Reapproved 2011), ASTM D5151-06 (Reapproved 2011) - Holes Inspection Level I AQL 2.5 | Meets ASTM D5151-06 (Reapproved 2011) - Holes Inspection Level I AQL 2.5 |
| Residual Powder | Meets ASTM D6124-06 (Reaffirmation 2011) | Results generated values below 2mg of residual powder (ASTM D6124-06 (Reaffirmation 2011)) |
| Materials Used | PVC | PVC |
| Dusting or Donning Powder | PU | PU (Surface Coating Agent) |
| Single Patient Use | Single Patient Use | Single Patient Use |
| Biocompatibility | SKIN IRRITATION DERMAL and SENSITIZATION STUDIES Meets ISO 10993-10:2002/Amd.1:2006 | The test article was a non-irritant or non-sensitizer. SKIN IRRITATION DERMAL and SENSITIZATION STUDIES Meets ISO 10993-10 Third Edition 2010-08-01 (This is comparable/equivalent to ISO 10993-10:2002/Amd.1:2006, likely an updated version of the standard with similar requirements) |
| Labeling | -Powder Free, -devices color: Clear(Non-colored), -Patient Examination Glove, -Non sterile, -Single Use Only, - Manufactured For:, - Lot | -Powder Free, -devices color: Clear(Non-colored), -Patient Examination Glove, -Non sterile, -Single Use Only, - Manufactured For:, - Lot |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document does not specify sample sizes for the individual tests (e.g., freedom from pinholes, tensile strength, etc.). It only states that the device "meets requirements per ASTM..." standards.
- The data provenance is not explicitly stated. The tests are framed as conformance to international standards (ASTM, ISO), which are generally performed in a controlled laboratory setting. The manufacturer is Feiyue Glove Co., Ltd., based in Hebei Province, China, so it's reasonable to assume the testing was conducted or overseen in that region. The studies are not described as retrospective or prospective in the medical imaging sense; they are laboratory-based performance tests of a manufactured product.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This information is not applicable to this type of device and study. The "ground truth" here is objective physical and chemical properties measured against established industry standards (ASTM, ISO). There are no human experts establishing ground truth in the context of diagnostic interpretation as would be seen in AI/ML medical devices. The "experts" would be laboratory technicians or engineers qualified to perform the specific ASTM/ISO tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies where human readers interpret data, and there are disagreements that need to be resolved to establish a consensus ground truth. For performance testing of a physical medical device against a standard, objective measurements are taken, and adjudication in this manner is not required.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- This is not applicable. MRMC studies are specifically designed for evaluating diagnostic devices, often AI-powered, by comparing the performance of multiple human readers with and without AI assistance across multiple cases. The provided document is for a non-AI, physical medical device (examination gloves).
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- This is not applicable. This describes an AI/ML algorithm's performance without human intervention. The device in question is a physical glove, not an algorithm. The reported performance is inherently "standalone" in that it pertains to the glove's intrinsic properties.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance is defined by established industry standards and specifications:
- ASTM D5250-06 (Reaffirmation 2011) for physical properties (dimensions, tensile strength, elongation).
- ASTM D5151-06 (Reapproved 2011) for freedom from pinholes.
- ASTM D6124-06 (Reaffirmation 2011) for residual powder.
- 21 CFR 800.20 for waterleak test on pinhole AQL.
- ISO 10993-10:2002/Amd.1:2006 (or the updated 2010 edition) for biocompatibility (skin irritation and sensitization).
- These standards specify the methodology and acceptable limits for various performance metrics, which serve as the "ground truth" for evaluating the glove.
8. The sample size for the training set
- This is not applicable. Training sets are relevant for AI/ML models. This document describes a manufactured product, and the "training" involves manufacturing processes and quality control to ensure the product consistently meets specifications, not an algorithmic learning process.
9. How the ground truth for the training set was established
- This is not applicable. As mentioned above, there is no "training set" in the context of an AI/ML device. The "ground truth" for the performance of the manufactured gloves is established by their adherence to the specified ASTM and ISO standards during production and quality assurance testing.
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Section C
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: ______________________________________________________________________________________________________________________________________________
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 : | Feiyue Glove Co., Ltd. | |
|---|---|---|
| Submitter's address : | Xixiangge Village, Sigezhuang Town, Luannan County,Hebei Province, 063502, China | |
| Phone number : | (86) 315- 4169201 | |
| Fax number" | (86) 315-4430333 | |
| Name of contact person: | Zhang Liang | |
| Date the summary was prepared: | 2014-05-03 |
[(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: | "Feiyue Powder Free Vinyl Patient Examination Gloves, Clear(non-colored)." |
| 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 : Powder free Vinyl Patient Examination Gloves, Clear(Non-colored), Tangshan Zhonghong Pulin Plastic Co.,Ltd.. K120968 .
Section C (rev.01)
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[(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).
-- How the device functions:
PVC films form a barrier to body fluids and bloodborne Pathogens
-- Scientific concepts that form the basis for the device
The PVC rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure.
-- Physical and performance characteristics such as design, materials and physical properties: PVC gloves are known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151 requirements.
[(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, Clear (Non-colored) non sterile are summarized with the following technological characteristics compared to ASTM or equivalent standard.
| Features& Description | Predicate Device | Subject Device | Result of Comparison |
|---|---|---|---|
| Company | Tangshan Zhonghong PulinPlastic Co.,Ltd. | Feiyue Glove Co., Ltd. | -- |
| 510(K) Number | K120968 | K140242 | |
| Product name | Powder Free Vinyl PatientExamination Gloves, Clear(Non-colored) | Powder Free Vinyl PatientExamination Gloves, Clear(Non-colored) | Same |
| Product Code | LYZ | LYZ | Same |
| Size | Small/ Medium/Large/X large | Small/ Medium/Large/X large | Substantiallyequivalent |
| Intend for use | Powder free Vinyl PatientExamination Gloves,Clear(Non-colored)is adisposable device intended formedical purposes that is worn onthe examiner's hand or finger toprevent contamination betweenpatient and examiner. | Powder free Vinyl PatientExamination Gloves, Clear(Non-colored) is a disposabledevice intended for medicalpurposes that is worn on theexaminer's hand or finger toprevent contaminationbetween patient and examiner. | Substantiallyequivalent |
| DeviceDescription andSpecifications | Meets ASTM D5250-06(Reapproved 2011) | Meets ASTM D5250 -06(Reapproved 2011) | Substantiallyequivalent |
| Dimensions-- Length | Meets ASTM D5250-06(Reapproved 2011) | Meets ASTM D5250-06(Reapproved 2011) | Substantiallyequivalent |
| ≥230mm min. | 230mm min for all sizes | ||
| Dimensions-- Width | Meets ASTM D5250-06(Reapproved 2011) | Meets ASTM D5250-06(Reapproved 2011) | Substantiallyequivalent |
| Small 80-90 mmrMedium 90-100mmLarge 100-110mmX large 110-120 mm | Small 85-88 mmMedium 94-97 mmLarge 103-106 mmX large 113-115 mm | ||
| Dimensions | Meets ASTM D5250-06 | Meets ASTM D5250-06 | |
| -- Thickness | (Reapproved 2011) | (Reapproved 2011) | |
| Finger 0.05mm min.Palm 0.08mm min. | Finger 0.05mm min.Palm 0.08mm min. | ||
| Physical Properties | Meets ASTM D5250-06(Reapproved 2011) | Meets ASTM D5250-06(Reapproved 2011) | Substantiallyequivalent |
| Before aging/after agingElongation ≥300%Tensile Strength≥11MPa | Before aging/after agingElongation ≥300%Tensile Strength≥ 11 MPa | ||
| Freedom fromPinholes | Meets21 CFR 800.20ASTM D5250-06(Reapproved 2011) | Meets ASTMD5151-06 (Reapproved 2011) | Substantiallyequivalent |
| • ASTM D 5151-06(Reapproved 2011) | HolesInspection Level IAQL2.5 | ||
| Residual Powder | Meets ASTMD6124-06 (Reaffirmation2011) | ASTM D6124-06(Reaffirmation 2011)Results generated valuesbelow 2mg of residual powder | Substantiallyequivalent |
| Compare allmaterials used tofabricate thedevices | PVC | PVC | Substantiallyequivalent |
| Dusting orDonning Powder: | PU | PU | Substantiallyequivalent |
| Dusting orDonning Powder:name | PU | Surface Coating Agent | Substantiallyequivalent |
| Compareperformance datasupportingsubstantialequivalence | MeetsASTM D5151-06(Reapproved 2011)ASTM D5250-06(Reapproved 2011)ASTM D6124-06(Reaffirmation 2011) | MeetsASTM D5151-06(Reapproved 2011)ASTM D5250-06(Reapproved 2011)ASTM D6124-06(Reaffirmation 2011) | Substantiallyequivalent |
| Single Patient Use | Single Patient Use | Single Patient Use | Substantiallyequivalent |
| Biocompatibility | SKIN IRRITATION DERMALand SENSITIZATIONSTUDIES Meets ISO10993-10:2002/Amd.1:2006 | The test article was a non-irritant or non- sensitizer.SKIN IRRITATIONDERMAL andSENSITIZATION STUDIESMeets ISO 10993-10 ThirdEdition 2010-08-01 | Substantiallyequivalent |
| Labeling for thelegally marketeddevice to whichsubstantialequivalence isclaimed. | -Powder Free-devices color:Clear(Non-colored)-Patient Examination Glove-Non sterile-Single Use Only- Manufactured For:- Lot | -Powder Free-devices color:Clear(Non-colored)-Patient Examination Glove-Non sterile-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(Reaffirmation 2011), per ASTM D6124-06(Reaffirmation 2011), per 21 CFR 800.20 and ISO 10993-10 Third Edition 2010-08-01.
[(b)(2)] A brief discussion of the clinical submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalence.
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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 and the Powder Free Vinyl Patient Examination Gloves, Clear (Non-colored) is as safe, as effective, and performs as well as the predicate device, Powder free Vinyl Patient Examination Gloves, Clear(Non-colored), Tangshan Zhonghong Pulin Plastic Co.,Ltd. K120968 .
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-000
June 12, 2014
Feivue Glove Co., Ltd % Chu Xiaoan Official Correspondent Room 1606 Bldg.1. Jianxiang Yuan No. 209 Bei Si Huan Zhong Road Haidian District Beijing, 100083 CHINA
K140242 Re:
Trade/Device Name: Powder Free Vinyl Patient Examination Gloves, Clear (Noncolored)
Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LYZ Dated: May 3, 2014 Received: May 15, 2014
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 - Chu 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 contact 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. 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.fdagov/MedicalDevices/ResourcesforYou/Industry/default.htm.
:
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Sincerely yours, Teiashri P Erin I. Keith, M.S. 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
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K140242
Device Name
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
Indications for Use (Describe)
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
A STERE OF CONSTITUTION FORIFORIFOR FOR FOR FOR THE CONTRACT CONTRACT CONTRACT ala - 1 - 10 -Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Sreekanth Gutala Digitally signed by Sreekanth Gutala -S
-S
DN: c=US, o=U.S. Government, ou=HHS, ou=FDA,
ou=People, 0.9.2342.19200300.100.1.1=2000540490,
cn=Sreekanth Gutala -S
Date: 2014.08.11 16:13:10 -04'00'
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FORM FDA 3881 (1/14)
§ 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.