(266 days)
KIT0945
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 Yellow Synthetic Vinyl Patient Examination Gloves", is intended to prevent contamination between patient and examiner, primarily for examination purposes, not for treating a disease or condition.
No
Explanation: The device is described as examination gloves, intended to prevent contamination between patient and examiner. Its function is protective, not to identify or monitor medical conditions.
No
The device is described as physical gloves, which are hardware, 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 clearly stated as a "disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner." This describes a barrier device used for infection control during physical examination.
- Device Description: The description focuses on the material and adherence to standards for examination gloves.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. IVDs are typically used in laboratories or point-of-care settings to analyze biological samples.
- Anatomical Site: The anatomical site is the "hand or finger," which is where the glove is worn, not where a specimen is collected or analyzed.
Therefore, this device falls under the category of a medical device used for barrier protection, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Powder Free Yellow Synthetic Vinyl Patient Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hand or linger to prevent comamination between patient and examiner.
Product codes
LYZ
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. 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
Hand or finger
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)
Powder Free Yellow Synthetic Vinyl Patient Examination Gloves meet requirements per ASTM D5250-06(Reaffirmation 2011), per ASTM D6124-06(Realfirmation 2011), per 21 CFR 800.20 and ISO 10993-10: 2002/Amd. 1:2006(E).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
KIT0945
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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: K131344 ." (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 :
Shijiazhuang Wally Plastic Co., Ltd. Submitter's name :
No. 78 Tongda Road, Jinzhou City. Hebei. 052260. China Submitter's address :
Zheng Jianming"
Phone number : (86) 31184322871
Fax number :
(86) 31184322871
Name of contact person:
18 Deceinber 2013 was Date. the summary prepared:
(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 |
Product Code :
[(a)(3)]. An identification of the legally marketed device to which your firm is claiming. substantial equivalence .
Class I . Powder Free Yellow Synthelie Vinyl Patient Examination Gloves that meets all of the requirements of AST M'standard D 5250-06 (Reaffirmation 2011):
-Predicate device : POWDER-FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, ZHAOYANG PLASTIC CO., LTD KIT0945
Section C (rev.02)
1
[(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. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure.
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- 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. 1 1 1 1 1 1 1 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 -
(a)(5)| The summary describes the intended use of the device
Device Intended Use: Powder Free Yellow Synthetic Vinyl Patient Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hand or linger to prevent comamination 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 | |
|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| 510(k) Number | K110945- | K131344 | | |
| Company | ZHAOYANG PLASTIC CO., LTD | Shijiazhuang Wally Plastic
Co., Ltd. | | |
| Product name | POWDER-FREE YELLOW
SYNTHETIC VINYL PATIENT
EXAMINATION GLOVES | Powder Free Yellow
Synthetic Vinyl Patient
Examination Gloves | | |
| Product Code | LYZ | LYZ | Same | |
| Size | Small/ Medium/
Large/X large | Small/ Medium/
Large/X large | Small/
Medium/
Large/X large | |
| Intend for use | POWDER-FREE YELLOW
SYNTHETIC VINYL PATIENT
EXAMINATION GLOVES 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 Yellow
Synthetic Vinyl Patient
Examination Gloves 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. | 230mm min for all sizes | Substantially
equivalent | |
| Dimensions
- Width | Meets ASTM D5250-06
(Reapproved 2011)
Small 80-90 mm | Small 80-85 mm | Substantially
equivalent | |
| | | | | |
| | Dimensions
-- Thickness | Medium 90-100mm
Large 100-110mm
X large 110-120 mm
Meets ASTM D5250-06
(Reapproved 2011) | Medium 95-97 mm
Large 102-108mm
X large 114-118 mm | Substantially
equivalent |
| | Physical
Properties | Finger 0.05mm min.
Palm 0.08mm min.
Meets ASTM D5250-06
(Reapproved 2011)
Before aging/after aging
Elongation ≥300%
Tensile Strength≥14MPa | Finger 0.05mm min.
Palm 0.08mm min.
Before aging/after aging
Elongation ≥300%
Tensile Strength≥14MPa | Substantially
equivalent |
| | 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
AQI 2.5 | Substantially
equivalent |
| | Residual Powder | Meets ASTM
D 6124-06
(Reapproved 2011) | D 6124-06
(Reapproved 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
(Reapproved 2011) | Meets
· ASTM D5151-06
(Reapproved 2011)
· ASTM D5250-06
(Reapproved 2011)
· ASTM D6124-06
(Reapproved 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 | The test article was a
non-irritant or
non-sensitizer.
SKIN IRRITATION
DERMAL and
SENSITIZATION STUDIES
Meets ISO 10993-10 | Substantially
equivalent. |
| | Labeling for the
legally marketed
device to which
substantial
equivalence is
claimed: | -Powder-free
-Patient Examination Glove
-Yellow color
-non sterile
-Single Use Only
-Manufactured For:
-Lot | -Powder-free
-Patient Examination Glove
-Yellow color
-non sterile
-Single Use Only
-Manufactured For:
-Lot | Substantially
equivalent |
2
:
3
(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 Gloves meet requirements per ASTM D5250-06(Reaffirmation 2011), per ASTM D6124-06(Realfirmation 2011), per 21 CFR 800.20 and ISO 10993-10: 2002/Amd. 1:2006(E).
[(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.
[(b)(3)] The conclusions drawn 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 YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, ZHIAOYANG PLASTIC CO., LTD K110945
Section C (rev:02)
ವಾ
4
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 30, 2014
Shijiazhuang Wally Plastics Company, Limited Mr. Chu Xiaoan Rm. 1606 Bldg.1 Jianxiang Yuan No.209 Bei Si Huan Zhong Road Haidian District Beijing, 100083 CHINA
Re: K131344
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: December 18, 2013 Received: December 20, 2013
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.
5
Page 2 - Mr. Xiaoan
a problem and security and the production of the section of the section of the section of the section of the section of the section of the section of the section of the secti
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 (2.1 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safetv/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
Sincerely vours.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
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Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K 131344
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 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)
SC Publishing Services (101) 443-6740
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
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FORM FDA 3881 (9/13)
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
7
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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
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