(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)." This device is a Class I medical device, and the submission primarily focuses on demonstrating substantial equivalence to a predicate device by meeting established industry standards. Therefore, the concept of "acceptance criteria" and "study" in this context refers to compliance with these standards and the tests performed to verify this compliance, rather than a clinical study of AI performance.
Here's an analysis of the provided text in the requested format:
Acceptance Criteria and Device Performance Study
The acceptance criteria for the "Powder Free Vinyl Patient Examination Gloves, Clear (Non-colored)" are primarily based on meeting the requirements of recognized ASTM standards (ASTM D5250-06 (Reaffirmation 2011), ASTM D5151-06 (Reaffirmed 2011), and ASTM D6124-06 (Reaffirmation 2011)) and biocompatibility testing (ISO 10993-10 Third Edition 2010-08-01). The study conducted involved non-clinical testing to demonstrate compliance with these standards.
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature/Test | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimensions - Length | ASTM D5250-06 (Reapproved 2011) - ≥230mm min. | Meets ASTM D5250-06 (Reapproved 2011) - 230mm min. for all sizes |
| Dimensions - Width | ASTM D5250-06 (Reapproved 2011) - Small 80-90mm, Medium 90-100mm, Large 100-110mm, X large 110-120mm | Meets ASTM D5250-06 (Reapproved 2011) - Small 84-86mm, Medium 95-98mm, Large 104-107mm, X large 110-115mm |
| Dimensions - Thickness | ASTM D5250-06 (Reapproved 2011) - Finger 0.05mm min., Palm 0.08mm min. | Meets ASTM D5250-06 (Reapproved 2011) - Finger 0.05mm min., Palm 0.08mm min. |
| Physical Properties (Before/After aging) | ASTM D5250-06 (Reapproved 2011) - Elongation ≥300%, Tensile Strength ≥11MPa | Meets ASTM D5250-06 (Reapproved 2011) - Elongation ≥300%, Tensile Strength ≥11MPa |
| Freedom from Pinholes | ASTM D5151-06 (Reapproved 2011) - Inspection Level 1, AQL 2.5 | Meets ASTM D5151-06 (Reapproved 2011) - Holes Inspection Level 1, AQL 2.5 |
| Residual Powder | ASTM D6124-06 (Reaffirmation 2011) | Results generated values below 2mg of residual powder (Meets ASTM D6124-06) |
| Biocompatibility | ISO 10993-10 Third Edition 2010-08-01 (Skin Irritation, Sensitization) | The test article was a non-irritant or non-sensitizer (Meets ISO 10993-10) |
| Water Leak Test on Pinhole | FDA Requirements | Meets FDA requirements |
2. Sample Size for Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for each specific test within the ASTM standards. However, testing according to ASTM standards typically involves specified sample sizes for various measurements (e.g., for physical properties, pinholes). The data provenance is implied to be from non-clinical laboratory testing performed by the manufacturer (Jiawang Glove Co., Ltd.) to demonstrate compliance with the referenced standards. This type of data is retrospective in the sense that it's gathered specifically for the regulatory submission after product manufacturing and testing. The country of origin for the studies would be China, where the manufacturer is located.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. For this type of device (patient examination gloves), "ground truth" is established through standardized physical and chemical testing methods as defined by ASTM and ISO standards, rather than through expert consensus on interpretations of complex data like medical images. These tests are performed by trained technicians in a laboratory setting.
4. Adjudication Method for the Test Set:
Not applicable. The tests are objective measurements against defined numerical or qualitative thresholds in the standards rather than requiring expert adjudication.
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 typically performed for diagnostic or AI-powered devices where human readers interpret medical cases. This device is a Class I physical barrier device, and its performance is evaluated against established physical and chemical standards.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This device is not an algorithm or AI system.
7. The Type of Ground Truth Used:
The "ground truth" for this device's performance is defined by the objective, quantitative, and qualitative limits specified in the referenced ASTM and ISO standards. For example, for "Freedom from Pinholes," the ground truth is "Inspection Level 1, AQL 2.5" as per ASTM D5151-06. For biocompatibility, the ground truth is "non-irritant or non-sensitizer" as determined by ISO 10993-10.
8. The Sample Size for the Training Set:
Not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set" in that context. The "training" for such devices involves adherence to manufacturing processes and material specifications to consistently produce gloves that meet the stated standards.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no "training set" in the context of AI. The "ground truth" for the device's design and manufacturing (which could be metaphorically considered its "training") stems from adherence to the specified materials (PVC, PU coating) and manufacturing processes designed to meet the performance criteria outlined in the ASTM and ISO standards.
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JUN 1 2 2014
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: K140239 " (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 : | Jiawang Glove Co., Ltd. |
|---|---|
| Submitter's address : | Menggezhuang, 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: | 2014-05-07 |
[(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: | "JIAWANG 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 mects 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.
| Features &Description | Predicate Device | Subject Device | Result of Comparison |
|---|---|---|---|
| Company | Tangshan Zhonghong PulinPlastic Co., Ltd. | Jiawang Glove Co., Ltd. | -- |
| 510(K) Number | K120968 | K140239 | |
| 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)230mm min for all sizes | Substantiallyequivalent |
| ≥230mm min. | |||
| Dimensions-- Width | Meets ASTM D5250-06(Reapproved 2011)Small 80-90 mmMedium 90-100mmLarge 100-110mmX large 110-120 mm | Meets ASTM D5250-06(Reapproved 2011)Small 84-86 mmMedium 95-98 mmLarge 104-107mmX large 110-115 mm | Substantiallyequivalent |
| Dimensions-- Thickness | Meets ASTM D5250-06(Reapproved 2011) | Meets ASTM D5250-06(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≥ 11MPa | ||
| 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 1AQL2.5 | Substantiallyequivalent |
| 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 | SubstantiallyequivalentSubstantiallyequivalent |
| 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 |
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.
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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)
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[(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
Jiawang Glove Company Limited C/O Mr. Chu Xiaoan Room 1606 Bldg.1. Jianxiang Yuan No. 209 Bei Si Huan Zhong Road Haidian District Beijing, 100083, CHINA
Re: K140239
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: January 27, 2014 Received: March 18, 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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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 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/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,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director
DAGRID/ODE/CDRH FOR
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) K140239
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.
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Type of Use (Select one or both, as applicable)
J 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 FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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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.