(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).
This submission is for a medical glove, which is a relatively simple device. The "acceptance criteria" and "study" framework usually applies to more complex diagnostic or therapeutic devices, especially those using AI. For a glove, the "acceptance criteria" are essentially the performance standards it needs to meet, and the "study" is the testing performed to show it meets those standards.
Here's the information extracted and adapted to your requested format, focusing on the device's characteristics and the standards it aims to meet:
Acceptance Criteria and Study for Powder Free Vinyl Patient Examination Gloves
This device, a Powder Free Vinyl Patient Examination Glove, Clear (non-colored), is designed to meet performance specifications outlined in ASTM standards and other regulations. Its "acceptance criteria" are these specific physical and performance properties, and the "study" demonstrating it meets these is the non-clinical testing against these established standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (ASTM/Regulatory Standard) | Reported Device Performance |
|---|---|
| Dimensions | |
| Length (ASTM D5250-06) | ≥230mm min. (for all sizes) |
| Width (ASTM D5250-06) | Small: 85-90 mmMedium: 95-97 mmLarge: 105-108 mmX large: 113-117 mm |
| Thickness (ASTM D5250-06) | Finger: 0.05mm min.Palm: 0.08mm min. |
| Physical Properties | |
| Elongation (Before aging/after aging, ASTM D5250-06) | ≥300% |
| Tensile Strength (Before aging/after aging, ASTM D5250-06) | ≥11MPa |
| Freedom from Pinholes | |
| Pinhole AQL (21 CFR 800.20, ASTM D5250-06, ASTM D5151-06) | Meets ASTM D5151-06 (Reapproved 2011), Holes Inspection Level I, AQL 2.5 |
| Residual Powder | |
| Residual Powder (ASTM D6124-06) | Results generated values below 2mg of residual powder |
| Biocompatibility | |
| Skin Irritation and Sensitization (ISO 10993-10:2002/Amd.1:2006 or 2010-08-01) | The test article was a non-irritant or non-sensitizer. Meets ISO 10993-10 Third Edition 2010-08-01 |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each individual test (e.g., how many gloves were tested for pinholes, or tensile strength). However, it implies adherence to the sampling plans and methodologies prescribed within the referenced ASTM and ISO standards for vinyl patient examination gloves.
- Data Provenance: The data provenance is from non-clinical bench testing performed by the manufacturer, Zhaofeng Glove Co., Ltd., to demonstrate compliance with international standards (ASTM, ISO, CFR). The country of origin for the manufacturing and testing is China. The data is prospective in the sense that the manufacturer conducted these tests specifically to demonstrate compliance for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable as this is a non-AI/software medical device. The "ground truth" for glove performance is defined by the objective, measurable parameters set by the cited ASTM and ISO standards, not by human expert opinion or interpretation of complex data. The tests are purely empirical.
4. Adjudication Method for the Test Set
This is not applicable for this type of device. Adjudication methods like 2+1 or 3+1 are used for human review processes (e.g., radiologist reads) to establish a consensus ground truth, which is not relevant here. The acceptance is determined by meeting objective numerical thresholds in physical tests.
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 or image-interpretation AI devices to compare human performance with and without AI assistance. This device is a physical barrier product, not a diagnostic tool requiring interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone performance evaluation was not done. This concept applies to AI algorithms. The device itself is a standalone physical product, and its performance is evaluated through direct physical and chemical testing.
7. The Type of Ground Truth Used
The "ground truth" for this device is based on objective, measurable physical and chemical properties and performance parameters defined by:
- ASTM D5250-06 (Reaffirmation 2011) - Standard Specification for Vinyl Patient Examination Gloves
- ASTM D5151-06 (Reapproved 2011) - Standard Test Method for Detection of Holes in Medical Gloves
- ASTM D6124-06 (Reaffirmation 2011) - Standard Test Method for Residual Powder on Medical Gloves
- 21 CFR 800.20 - General provisions for medical devices (specifically regarding barrier integrity)
- ISO 10993-10:2002/Amd.1:2006 or ISO 10993-10 Third Edition 2010-08-01 - Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
8. The Sample Size for the Training Set
This is not applicable. There is no "training set" as this is not an AI or machine learning device. The glove is manufactured to a specified design and material, and its performance is verified through testing of manufactured lots against established standards, not through training an algorithm.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set for this type of device.
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Section C
JUN 1 2 2014
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."
" (applicant leave blank) "The assigned 510(k) number is: K140240
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 : | Zhaofeng Glove Co., Ltd. | ||
|---|---|---|---|
| Submitter's address : | Jialinzi, Sigezhuang Town, Luannan County, HebeiProvince, 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: | "Zhaofeng Powder Free Vinyl Patient Examination Gloves,Clear (non-colored)" |
| Common Name: | Patient examination glove |
| Classification Name: | Patient examination glove |
| Device Classification: | 1 |
| 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 .
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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 Pulin Plastic Co., Ltd. | Zhaofeng Glove Co., Ltd. | -- |
| 510(K) Number | K120968 | K140240 | |
| Product name | Powder Free Vinyl Patient Examination Gloves, Clear (Non-colored) | Powder Free Vinyl Patient Examination Gloves, Clear (Non-colored) | Same |
| Product Code | LYZ | LYZ | Same |
| Size | Small/ Medium/ Large/X large | Small/ Medium/ Large/X large | Substantially equivalent |
| Intend for 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. | 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. | Substantially equivalent |
| Device Description and Specifications | Meets ASTM D5250-06 (Reapproved 2011) | Meets ASTM D5250 -06 (Reapproved 2011) | Substantially equivalent |
| Dimensions -- Length | Meets ASTM D5250-06 (Reapproved 2011) | Meets ASTM D5250-06 (Reapproved 2011) | Substantially equivalent |
| ≥230mm min. | 230mm min for all sizes | ||
| Dimensions -- Width | Meets ASTM D5250-06 (Reapproved 2011) | Meets ASTM D5250-06 (Reapproved 2011) | Substantially equivalent |
| Small 80-90 mmMedium 90-100mmLarge 100-110mmX large 110-120 mm | Small 85-90 mmMedium 95-97 mmLarge 105-108mmX large 113-117 mm | ||
| Dimensions Thickness | Meets ASTM D5250-06 (Reapproved 2011) | Meets ASTM D5250-06 (Reapproved 2011) | |
| Physical Properties | Finger 0.05mm min.Palm 0.08mm min.Meets ASTM D5250-06(Reapproved 2011)Before aging/after agingElongation ≥300%Tensile Strength≥11MPa | Finger 0.05mm min.Palm 0.08mm min.Meets ASTM D5250-06(Reapproved 2011)Before aging/after agingElongation ≥300%Tensile Strength≥ 11MPa | Substantially equivalent |
| Freedom fromPinholes | Meets- 21 CFR 800.20- ASTM D5250-06(Reapproved 2011)- ASTM D 5151-06(Reapproved 2011) | Meets ASTMD5151-06 (Reapproved 2011)HolesInspection Level IAQL2.5 | Substantially equivalent |
| Residual Powder | Meets ASTMD6124-06 (Reaffirmation 2011) | ASTM D6124-06 (Reaffirmation 2011)Results generated values below 2mg of residual powder | Substantially equivalent |
| Compare allmaterials used tofabricate thedevices | PVC | PVC | Substantially equivalent |
| Dusting orDonning Powder: | PU | PU | Substantially equivalent |
| Dusting orDonning Powder:name | PU | Surface Coating Agent | Substantially equivalent |
| 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) | Substantially equivalent |
| Single Patient Use | Single Patient Use | Single Patient Use | Substantially equivalent |
| 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 | Substantially equivalent |
| Labeling for thelegally marketeddevice to whichsubstantialequivalence isclaimed. | -Powder Free-devices color:Clear(Non-colored)-Patient Examination Glove-Non sterile-Single Use Only-Manufactured For: | -Powder Free-devices color:Clear(Non-colored)-Patient Examination Glove-Non sterile-Single Use Only-Manufactured For: | Substantially equivalent |
Section C (rev.01)
Page 2/4
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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.
Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.
Section C (rev.01)
Page 3/4
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[(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 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
Zhaofeng Glove Company, Limited C/O Mr. Chu Xiaoan Official Correspondent Room 1606 Bldg.1. Jianxiang Yuan No. 209 Bei Si Huan Zhong Road Haidian District Beijing, 100083, CHINA
Re: K140240
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: 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 Federal Register.
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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 tollfree 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" (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, Teiashri Priro 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) K140240
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.
FOR FOR FOR FOR FOR FOR A THE ONLY : : : Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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c=US, o=U.S. Government, ou=HHS, ou=FDA, People, 0.9.2342.19200300.100.1.1=2000540490, Sreekanth Gutala -S 2014.06.11 15:58:35 -04'00'
Digitally signed by Sreekanth Gutala -S
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§ 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.