(111 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). PVC films form a barrier to body fluids and bloodborne Pathogens. 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. 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.
The document provided is a 510(k) Premarket Notification Summary for Powder-Free Vinyl Patient Examination Gloves, Clear (Non-colored). This type of device is classified as a Class I medical device, which means it is subject to general controls and does not typically require extensive clinical data for market clearance. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: Powder-Free Vinyl Patient Examination Gloves, Clear (Non-colored)
Predicate Device: Powder free Vinyl Patient Examination Gloves, Clear(Non-colored), Tangshan Zhonghong Pulin Plastic Co.,Ltd.. K120968.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are primarily based on established industry standards, specifically ASTM standards for medical examination gloves. The device's performance is compared against these standards and to the predicate device.
| Acceptance Criterion (Standard) | Reported Device Performance (Subject Device) | Result of Comparison to Predicate/Standard |
|---|---|---|
| Dimensions - Length: Meets ASTM D5250-06 (Reapproved 2011) | Meets ASTM D5250-06 (Reapproved 2011) | Substantially equivalent |
| Specific Length Range: | 231-250 mm (Predicate: 232-249mm) | Substantially equivalent |
| Dimensions - Width: Meets ASTM D5250-06 (Reapproved 2011) | Meets ASTM D5250-06 (Reapproved 2011) | Substantially equivalent |
| Specific Width Ranges: | Small 84-87 mm; Medium 94-97 mm; Large 103-107mm; X large 111-114 mm (Predicate: Small 80-90 mm; Medium 90-100mm; Large 100-110mm; X large 110-120 mm) | Substantially equivalent |
| Dimensions - Thickness: Meets ASTM D5250-06 (Reapproved 2011) | Meets ASTM D5250-06 (Reapproved 2011) | Substantially equivalent |
| Specific Thickness: | Finger: 0.08-0.10mm; Palm: 0.08-0.11mm (Predicate: Finger 0.08-0.10mm; Palm: 0.08-0.10mm) | Substantially equivalent |
| Physical Properties - Elongation: (Meets ASTM D5250-06) | Before aging: 330-420%; After aging: 350-410% (Predicate: Before aging: 360-500%; After aging: 350-400%) | Substantially equivalent |
| Physical Properties - Tensile Strength: (Meets ASTM D5250-06) | Not explicitly stated in numerical range for the subject device. Implied to meet ASTM standard. (Predicate: Not explicitly stated in numerical range.) | Substantially equivalent |
| Freedom from Pinholes: Meets 21 CFR 800.20, ASTM D5250-06, ASTM D5151-06 (Reapproved 2011) | Meets ASTM D5151-06 (Reapproved 2011) Holes Inspection Level I, AQL 2.5 (Predicate: Meets • 21 CFR 800.20 • ASTM D5250-06 • ASTM D 5151-06 (Reapproved 2011)) | Substantially equivalent |
| Residual Powder: Meets ASTM D6124-06 (Reaffirmation 2011) | Residual powder mean 0.6mg (Predicate: Residual powder mean 1.7mg) | Substantially equivalent |
| Biocompatibility: Meets ISO 10993-10:2002/Amd.1:2006 (for predicate) / ISO 10993-10 Third Edition 2010-08-01 (for subject device) | Under the conditions of this study, the test article was a non-irritant and non-sensitizer (SKIN IRRITATION DERMAL and SENSITIZATION STUDIES). (Predicate: non-irritant and non-sensitizer for SKIN IRRITATION DERMAL and SENSITIZATION STUDIES.) | Substantially equivalent |
| Materials Used: PVC | PVC | Substantially equivalent |
| Dusting or Donning Powder: PU | PU / Surface Coating Agent | Substantially equivalent |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the specific sample sizes used for each test (e.g., number of gloves tested for pinholes, tensile strength, etc.). However, it refers to compliance with ASTM standards (e.g., D5250, D5151, D6124), which inherently define the statistical sampling plans and methodologies for testing.
- Data Provenance: The tests for the subject device were likely conducted by or for Tangshan Hongyun Plastic Products Co., Ltd. in China, as indicated by the submitter's address. The data is retrospective in the sense that the testing was performed on the manufactured devices to demonstrate compliance with standards and equivalence to the predicate.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
For this type of device (medical examination gloves), the "ground truth" is established by conformity to recognized international and national standards (e.g., ASTM, ISO, 21 CFR) rather than expert consensus on interpretive tasks. Therefore:
- Number of Experts: Not applicable in the sense of medical diagnosticians establishing interpretations. The "expertise" lies in the development and validation of the ASTM and ISO standards themselves, and the accreditation of testing laboratories that perform these physical and chemical evaluations.
- Qualifications of Experts: The experts involved would be those who develop and interpret the ASTM and ISO standards, and the qualified personnel in
testing laboratories (e.g., chemists, material scientists, quality engineers) who perform the required tests according to those standards.
4. Adjudication Method for the Test Set
Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human interpretation (e.g., radiology reads) to resolve disagreements among experts. This is not applicable here because the acceptance criteria are based on objective physical and chemical measurements against pre-defined, quantitative standards. The "adjudication" is inherent in the test method specified by the ASTM/ISO standard; if a test result falls outside the specified range, the sample (or batch) fails.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. MRMC studies are relevant for devices that involve human interpretation of diagnostic images or data (e.g., CAD systems for mammography). This device (examination gloves) does not involve human readers or case interpretation in a diagnostic context. Its effectiveness is based on its physical barrier properties and biocompatibility.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable to the device. A standalone study typically refers to the performance of an AI algorithm operating independently without human intervention. The device in question is a physical medical device (gloves) and does not involve any AI algorithms.
7. The Type of Ground Truth Used
The "ground truth" for these gloves is defined by:
- Objective Measurement against Standards: The physical and performance characteristics (e.g., dimensions, tensile strength, elongation, freedom from pinholes, residual powder) are compared against the quantitative specifications outlined in ASTM D5250-06, ASTM D5151-06, and ASTM D6124-06.
- Biocompatibility Testing: The "ground truth" for biocompatibility (irritation and sensitization) is established through ISO 10993-10 compliant tests. The outcome of these tests determines if the material is deemed non-irritant and non-sensitizer according to established biological safety criteria.
8. The Sample Size for the Training Set
This question is not applicable. Since the device is a physical medical product and not an AI/ML algorithm or a diagnostic tool, there is no "training set" in the context of machine learning. The manufacturing process is controlled by Good Manufacturing Practices (GMP), and quality control tests (like those mentioned in ASTM standards) are performed on batches of products.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable because, as stated above, there is no "training set" for this device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 10, 2014
Tangshan Hongyun Plastic Products Co., Ltd. C/O Mr. Chu Xiaoan Jianxiang Yuan No. 209 Bei Si Huan Zhong Road, Haidian District Room 1606 Bldg. 1 Beijing, 100083 CHINA
Re: K142343
Trade/Device Name: Powder-Free Vinyl Patient Examination Gloves, Clear (Non-colored) Regulation Number: 21 CFR 880.6250 Regulation Name: Vinyl Patient Examination Gloves Regulatory Class: I Product Code: LYZ Dated: October 24, 2014 Received: October 30, 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 tollfree 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.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Teiashri 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
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Indications for Use
510(k) Number (if known) K 142343
Device Name
Powder-Free Vinyl Patjent 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)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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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 : | Tangshan Hongyun Plastic Products Co.,ltd |
|---|---|
| Submitter's address : | South Shenggezhuang Village, Pachigang Town, LuannanCounty, 063502,Hebei Province,China |
| Phone number : | (86)315-4169377 |
| Fax number : | (86)315-4169376 |
| Name of contact person: | RJ Wang |
| Date the summary was prepared: | 2014-10-24 |
[(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, 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 .
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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 ofComparison |
|---|---|---|---|
| Company | Tangshan Zhonghong Plastic Co.,Ltd. | Tangshan Hongyun Plastic Products Co.,ltd | -- |
| 510(K) Number | K120968 | K142343 | |
| 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 contamination betweenpatient 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 |
| 232-249mm | 231-250 mm | ||
| Dimensions-- Width | Meets ASTM D5250-06(Reapproved 2011) | Meets ASTM D5250-06(Reapproved 2011) | Substantiallyequivalent |
| Small 80-90 mmMedium 90-100mmLarge 100-110mmX large 110-120 mm | Small 84-87 mmMedium 94-97 mmLarge 103-107mmX large 111-114 mm | ||
| Dimensions-- Thickness | Meets ASTM D5250-06(Reapproved 2011) | Meets ASTM D5250-06(Reapproved 2011) | 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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| Physical Properties | Finger 0.08-0.10mm.Palm: 0.08-0.10mm.Meets ASTM D5250-06(Reapproved 2011) | Finger: 0.08-0.10mm.Palm: 0.08-0.11mm.Meets ASTM D5250-06(Reapproved 2011) | Substantiallyequivalent | ||||
|---|---|---|---|---|---|---|---|
| Elongation | Beforeaging | Afteraging | Elongation | Beforeaging | After aging | ||
| TensileStrength | 360-500% | 350-400% | TensileStrength | 330-420% | 350-410% | ||
| Freedom fromPinholes | Meets• 21 CFR 800.20• ASTM D5250-06(Reapproved 2011)• ASTM D 5151-06(Reapproved 2011) | Meets ASTM D5151-06(Reapproved 2011)HolesInspection Level IAQL2.5 | Substantiallyequivalent | ||||
| Residual Powder | Meets ASTM D6124-06(Reaffirmation 2011)Residual powder mean 1.7mg | Meets ASTM D6124-06(Reaffirmation 2011)Residual powder mean 0.6mg | 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 | Under the conditions of thisstudy, the test article was anon-irritant and non-sensitizer.SKIN IRRITATION DERMALand SENSITIZATIONSTUDIES Meets ISO10993-10:2002/Amd.1:2006 | Under the conditions of this study,the test article was a non-irritantand non-sensitizer.SKIN IRRITATION DERMALand SENSITIZATION 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 |
[(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 .
§ 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.