(248 days)
Powder-Free Yellow Synthetic Vinyl Patient Examination Gloves 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 Yellow Synthetic Vinyl Patient Examination Gloves that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011).
The provided text details the 510(k) summary for the "Powder-Free Yellow Synthetic Vinyl Patient Examination Gloves" (K141224), demonstrating its substantial equivalence to a predicate device. The information below is extracted and organized to address your request, focusing on acceptance criteria and the study proving compliance.
1. Table of Acceptance Criteria and Reported Device Performance
The device is evaluated against the ASTM D5250-06 (Reaffirmation 2011) standard, ASTM D5151-06 (Reapproved 2011), ASTM D6124-06 (Reaffirmation 2011), and ISO 10993-10 Third Edition 2010-08-01 for biocompatibility.
| Acceptance Criteria (Standard & Characteristic) | Device Performance (Subject Device K141224) | Result |
|---|---|---|
| ASTM D5250-06 (Reaffirmation 2011) | ||
| - Length | ≥230mm min. for all sizes | Meets |
| - Width (Small) | 83-87 mm | Meets |
| - Width (Medium) | 94-97 mm | Meets |
| - Width (Large) | 103-107mm | Meets |
| - Width (X Large) | 113-116 mm | Meets |
| - Thickness (Finger) | 0.05mm min. | Meets |
| - Thickness (Palm) | 0.08mm min. | Meets |
| - Physical Properties (Before aging): | Elongation ≥300%, Tensile Strength ≥14MPa | Meets |
| - Physical Properties (After aging): | Elongation ≥300%, Tensile Strength ≥14MPa | Meets |
| ASTM D5151-06 (Reapproved 2011) | ||
| - Freedom from Pinholes | Inspection Level I, AQL 2.5 (Meets 21 CFR 800.20) | Meets |
| ASTM D6124-06 (Reaffirmation 2011) | ||
| - Residual Powder | Generated values below 2mg of residual powder | Meets |
| ISO 10993-10 Third Edition 2010-08-01 | ||
| - Biocompatibility (Skin Irritation) | Not an irritant under the conditions of the study | Meets |
| - Biocompatibility (Sensitization) | Not a sensitizer under the conditions of the study | Meets |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for the individual tests (e.g., pinhole, tensile strength, residual powder). It only states that the device "meets" the requirements of the standards. The data provenance is implied to be from the manufacturer, Shijiazhuang Jiuyuan Plastic Co., Ltd. for the subject device, and Hebei Leader Plastic Co., Ltd. for the predicate device. The nature of the studies (retrospective or prospective) is not explicitly mentioned but typically for these types of device clearances, the performance data would be generated prospectively during product development and testing. The country of origin of the data is China, as both the submitter and predicate device manufacturer are based in China.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a patient examination glove, and the "ground truth" for its performance is established by standardized physical and chemical tests, not by expert interpretation of patient data or images. The tests are designed to objectively measure properties like tensile strength, pinholes, and biocompatibility.
4. Adjudication method for the test set
Not applicable. The "ground truth" for this device is based on objective measurements and compliance with established ASTM and ISO standards, not on subjective assessments requiring adjudication.
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
Not applicable. This device is a physical product (patient examination glove), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a physical product, not an algorithm.
7. The type of ground truth used
The ground truth used for this device's acceptance is based on:
- Industry Standards: Compliance with specific physical and chemical property limits defined by ASTM International standards (D5250-06, D5151-06, D6124-06).
- Biocompatibility Standards: Compliance with limits defined by ISO (10993-10).
- Regulatory Requirements: Compliance with regulations like 21 CFR 800.20 for freedom from pinholes.
These standards serve as the objective "ground truth" against which the device's performance is measured.
8. The sample size for the training set
Not applicable. This device is a physical product, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for a physical product, there is no ground truth established for one.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 15, 2015
Shijiazhuang Jiuyuan Plastic Co., Ltd. c/o Mr. Chu Xiaoan Room 1606 Bldg 1 Jianxiang Yuan No. 209 Bei Si Huan Zhong Road, Haidian District Beijing 100083 CHINA
Re: K141224
Trade/Device Name: Powder Free Yellow Synthetic Vinyl Patient Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: November 4, 2014 Received: November 17, 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,
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
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Indications for Use
510(k) Number (if known) K141224
Device Name
Powder-Free Yellow Synthetic Vinyl Patient Examination Gloves
Indications for Use (Describe)
Powder-Free Yellow Synthetic Vinyl Patient Examination Gloves 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 : | Shijiazhuang Jiuyuan Plastic Co., Ltd |
|---|---|
| Submitter's address : | Xibaipo Industry Park, Pingshan County, Shijiazhuang,050000, Hebei, China |
| Phone number : | (86) 311-67699606 |
| Fax number : | (86) 311-67699906 |
| Name of contact person: | Zhang Lei |
| Date the summary was prepared: | 2014-11-04 |
[(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 Yellow Synthetic Vinyl Patient Examination Gloves |
|---|---|
| Proprietary/Trade name: | "Powder-Free Yellow Synthetic Vinyl Patient Examination Gloves" |
| 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 Yellow Synthetic Vinyl Patient Examination Gloves that meets all of the requirements of ASTM standard D 5250-06 (Reaffirmation 2011).
Predicate device: Powder Free Vinyl Patient Examination Gloves. Colored (Yellow), Hebei Leader Plastic Co., Ltd. K122920.
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[(a)(4)] A description of the device
Device Description: Powder-Free Yellow Synthetic Vinyl Patient Examination Gloves 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. Its 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 Yellow Synthetic Vinyl Patient Examination Gloves 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.
[(a)(6)] A summary of the technological characteristics of new device compared to the predicate device.
The Powder-Free Yellow Synthetic Vinyl Patient Examination Gloves 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 | Hebei Leader Plastic Co., Ltd. | Shijiazhuang Jiuyuan Plastic Co., Ltd | -- |
| 510(K) Number | K122920 | K141224 | |
| Product name | Powder-Free Vinyl Patient Examination Gloves, Yellow Color | Powder-Free Yellow Synthetic Vinyl Patient Examination Gloves | 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. Colored (Yellow) 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 Yellow Synthetic Vinyl Patient Examination Gloves 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. | 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)≥230mm min. | Meets ASTM D5250-06 (Reapproved 2011)230mm min for all sizes | Substantially equivalent |
| 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 83-87 mmMedium 94-97 mmLarge 103-107mmX large 113-116 mm | Substantially equivalent |
| 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≥14MPa | Before aging/after agingElongation ≥300%Tensile Strength≥ 14MPa | ||
| FreedomfromPinholes | 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 | Substantiallyequivalent |
| Residual Powder | Meets ASTMD6124-06(Reaffirmation2011) | ASTM D6124-06(Reaffirmation 2011)generatedvaluesbelow 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 | Under the conditions of thestudy, not an irritant and underconditions of the study, not asensitizer.SKIN IRRITATIONDERMAL andSENSITIZATION STUDIESMeets ISO 10993-10 ThirdEdition 2010-08-01 | Substantiallyequivalent |
| Labeling for thelegally marketeddevice to whichsubstantialequivalence isclaimed. | -Powder Free-Devices color: Yellow-Patient Examination Glove-Non sterile-Single Use Only-Manufactured For:- Lot | -Powder Free-Devices color: Yellow-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 Yellow Synthetic Vinyl Patient Examination Glovesmeet 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 Yellow Synthetic Vinyl Patient Examination Gloves is as safe, as effective, and performs as well as the predicate device Powder Free Vinyl Patient Examination Gloves. Colored (Yellow), Hebei Leader Plastic Co., Ltd. K122920.
§ 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.