(140 days)
Not Found
No
The device is a simple examination glove and the summary contains no mention of AI, ML, or any related technologies.
No
The device, "Powder Free Vinyl Patient Examination Gloves," is described as a non-sterile disposable device intended to prevent contamination between patient and examiner. It does not provide any therapeutic effect or treatment.
No
The device is described as a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination, which is a protective barrier function, not a diagnostic one.
No
The device is described as physical examination gloves, which are a hardware medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to prevent contamination between patient and examiner by being worn on the hand or finger. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description focuses on the material and standards related to gloves, not on any components or processes used for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's health status.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
LYZ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Examiner (medical purposes)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical tests were conducted to demonstrate 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. The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performed as well or better than the legally marketed device. It meets the ASTM standard or equivalent standard and FDA requirements for waterleak test on pinhole AQL, and meets labeling claims. Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of three human profiles facing right, stacked on top of each other. The profiles are black and are set against a white background. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 16, 2014
Zibo Yusheng Plastic Products Company Limited C/O Mr. Chu Xiaoan Official Correspondent Beijing Easy-Link Co. Room 1606 Bldg 1 Yuan #209 Bei Si Huan Zhong Road, Haidian District Beijing, PR China 100083
Re: K141108
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: August 11, 2014 Received: August 14, 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.
1
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 Industry and Consumer Education 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 Industry and Consumer Education 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
Enclosure
2
Indications for Use
510(k) Number (if known) K141108
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 FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
3
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 : | Zibo Yusheng Plastic Products Company Limited |
|---|---|
| Submitter's address : | Li Wang Village, Zhoujia District, Hengtai County Zibo, |
| Shandong, 255414, China | |
| Phone number : | (86)533-3819127 |
| Fax number : | (86)533-3819127 |
| Name of contact person: | Cherry Xu |
| Date the summary was prepared: | 2014-08-11 |
[(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 k nown
| 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 .
4
[(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 formthe basis for the device
The PVC rubber is water tight under normal conditions of use. It's tensile properties cause it to conformto 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 intendeduse 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 Pulin Plastic Co.,Ltd. | Zibo Yusheng Plastic Products Company Limited | -- |
| 510(K) Number | K120968 | K141108 | |
| 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) |
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 mm
Medium 90-100mm
Large 100-110mm
X large 110-120 mm | Meets ASTM D5250-06 (Reapproved 2011)
Small 84-86 mm
Medium 94-96 mm
Large 104-106mm
X large 113-115 mm | Substantially equivalent |
| 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) | Substantially
equivalent |
| | Before aging/after aging
Elongation ≥300%
Tensile Strength $\geq$ 11MPa | Before aging/after aging
Elongation ≥300%
Tensile Strength $\geq$ 11MPa | |
| Freedom from
Pinholes | Meets
- 21 CFR 800.20
- ASTM D5250-06
(Reapproved 2011) - ASTM D 5151-06
(Reapproved 2011) | Meets ASTM
D5151-06 (Reapproved 2011)
Holes
Inspection Level I
AQL2.5 | Substantially
equivalent |
| Residual Powder | Meets ASTM
D6124-06 (Reaffirmation
-
| ASTM D6124-06
(Reaffirmation 2011)
Results generated values
below 2mg of residual powder | Substantially
equivalent |
| Compare all
materials used to
fabricate the
devices | PVC | PVC | Substantially
equivalent |
| Dusting or
Donning Powder: | PU | PU | Substantially
equivalent |
| Dusting or
Donning Powder:
name | PU | Surface Coating Agent | Substantially
equivalent |
| Compare
performance data
supporting
substantial
equivalence | Meets
ASTM D5151-06
(Reapproved 2011)
ASTM D5250-06
(Reapproved 2011)
ASTM D6124-06
(Reaffirmation 2011) | Meets
ASTM 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 DERMAL
and SENSITIZATION
STUDIES Meets ISO
10993-10:2002/Amd.1:2006 | Under the conditions of the
study, the device is not a
sensitizer or an irritant.
SKIN IRRITATION
DERMAL and
SENSITIZATION STUDIES
Meets ISO 10993-10 Third
Edition 2010-08-01 | Substantially
equivalent |
| Labeling for the
legally marketed
device to which
substantial
equivalence is
claimed. | -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 | Substantially
equivalent |
The Powder-Free Vnyl Patient Examination Gloves, Clear (Non-colored) non sterile are summarized with the following technological characteristics compared to ASTM or equivalent standard.
5
[(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.
6
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 tests that demonstrate that the device is as safe, as effective, and performed as well or better than the legally marketed device identifiedin (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 Vmyl Patient Examination Gloves, Clear (Non-colored) is as safe, as effective, and performs as well as the predicatedevice, Powder free Vinyl Patient Examination Gloves, Clear(Non-colored), Tangshan Zhonghong Pulin Plastic Co.,Ltd. K120968 .