(100 days)
Not Found
No
The document describes a standard examination glove and its physical and performance characteristics, with no mention of AI or ML technology.
No.
The device, a patient examination glove, is intended for preventing contamination, not for treating or diagnosing a disease or condition.
No
Explanation: The device is a patient examination glove, described as a non-sterile device worn on the hand or finger to prevent contamination. Its purpose is protective, not diagnostic.
No
The device description clearly states it is a physical glove made of vinyl and oil-based liquid nitrile rubber materials, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "patient examination glove... to prevent contamination between patient and examiner." This is a barrier device, not a device used to diagnose a condition based on in vitro examination of specimens.
- Device Description: The description focuses on the physical properties and materials of the glove, not on any diagnostic function.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
- Performance Studies: The performance studies listed are related to the physical integrity and biocompatibility of the glove (tensile strength, pinhole, irritation, sensitization), which are relevant for a barrier device, not an IVD.
- Key Metrics: The "Not Found" for key metrics like Sensitivity, Specificity, PPV, and NPV further indicates it's not an IVD, as these are standard metrics for evaluating diagnostic performance.
This device is a medical device, specifically a Class I or Class II barrier device, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
A patient examination glove is disposable non-sterile device intended for medical purpose 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
Vinyl Co-Polymer Powder Free Examination Gloves, Blue Color are Patient Examination Gloves, Disposable, single use only and non-sterile. The gloves are made of vinyl and oil-based liquid nitrile rubber materials and are powder free. The physical and performance characteristics of the devices meet all requirements of ASTM D5250-06 (Reapproved 2011) Standard Specification For Poly (Vinyl Chloride) Gloves For Medical Application.
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
Not Found
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)
Non-clinical tests were performed to determine substantial equivalence.
Testing Items and Results:
- Overall Length: 239mm (Pass, Standard: 230 for all sizes min)
- Width: S: 87, M: 97, L: 107, XL: 118 (Pass, Standard: S: 85±5, M: 95±5, L: 105±5, XL: 115±5)
- Palm Thickness: 0.08mm (Pass, Standard: 0.08mm min)
- Finger Thickness: 0.10mm (Pass, Standard: 0.05mm min)
- Tensile Strength (Before aging): 15.2Mpa min (Pass, Standard: 11Mpa min)
- Tensile Strength (After aging): 14.6Mpa min (Pass, Standard: 11Mpa min)
- Ultimate Elongation (Before aging): 390% min (Pass, Standard: 300% min)
- Ultimate Elongation (After aging): 360% min (Pass, Standard: 300% min)
- Pinhole: AQL1.5 (Pass, Standard: 2.5)
- Residual Powder: Not more than 2mg per glove (Pass, Standard: Not more than 2mg per glove)
- Primary Skin Irritation Test: Under conditions of the study, not an irritant
- Dermal Sensitization Study: Under conditions of the study, not an irritant
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a caduceus, with three overlapping profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 5,2014
Grand Work Plastic Products Company Limited C/O Ms. Kathy Liu Hongray USA Medical Products Incorporated 3973 Schaefer Avenue Chino, CA 91710
Re: K142409
Trade/Device Name: Vinyl Co-Polymer Powder-free Examination Gloves, Blue Color Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: October 31, 2014 Received: November 5, 2014
Dear Ms. Liu:
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 - Ms. Liu
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,
Susan Runco, DDS, MA
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) K142409
Device Name
Vinyl Co-Polymer Powder Free Examination Gloves, Blue Color
Indications for Use (Describe)
A patient examination glove is disposable non-sterile device intended for medical purpose 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)
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Donggao Industrial Zone Zanhuang, Hebei, China 050000
510(K) SUMMARY
This summary of 510(K) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR $807.92.
The assigned 510(K) number is: K142409
Date Summary Prepared: December 3, 2014
1. Owner's Identification:
Grand Work Plastic Products Co., Ltd. Donggao Industrial Zone Zanhuang, Hebei, China 050000 Tel: +86-0311-83980225 Fax: +86-0311-83634221 Contact: Ms. May Jia Position title: Project Manager
2. Name of the Device:
Trade Name: Vinyl Co-Polymer Powder Free Examination Gloves, Blue Color Common Name: Exam Gloves Classification Name: Patient Examination Glove Classification Regulation: 880.6250 Classification Panel: 880 General Hospital Product Code: LYZ Device Class: Class I
3. Predicate Device Information:
Grand Work Plastic Products Co., Ltd. Vinyl Co-Polymer Powder Free Examination Gloves, Blue Color (K061562)
4. Device Description:
Vinyl Co-Polymer Powder Free Examination Gloves, Blue Color are Patient Examination Gloves, Disposable, single use only and non-sterile. The gloves are made of vinyl and oil-based liquid nitrile rubber materials and are powder free. The physical and performance characteristics of the devices meet all requirements of ASTM D5250-06 (Reapproved 2011) Standard Specification For Poly (Vinyl Chloride) Gloves For Medical Application.
5. Intended Use of the Device:
A patient examination glove is disposable non-sterile device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
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Donggao Industrial Zone Zanhuang, Hebei, China 050000
6. Technological Characteristics and Substantial Equivalence:
Grand Work Plastic Products Co., Ltd.'s Vinyl Co-Polymer Powder Free Examination Gloves, Blue Color is substantially equivalent in safety and effectiveness to the Grand Work Plastic Products Co., Ltd. 's Vinyl Co-Polymer Powder Free Examination Gloves, Blue Color (K 061562). The subject device and predicate device use a similar plastic flexible barrier film to achieve a device for the intended use.
And the properties between the subject device and the predicate device are compared in the following table:
| Characteristics | Device Performance | | Result of
comparison | |
|------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|-----------------------------------------------------|
| | Predicate device
K061562 | Subject Device
K142409 | | |
| Product Code | LYZ | LYZ | Similar | |
| Indications For Use | Predicate device is
disposable non-sterile
device intended for medical
purpose that is worn on the
examiner's hand or finger to
prevent contamination
between patient and
examiner. | Subject device is disposable
non-sterile device intended
for medical purpose that is
worn on the examiner's
hand or finger to prevent
contamination between
patient and examiner. | Similar | |
| Labeling | It is Patient Examination
Glove, Disposable, single
use only and non-sterile | It is Patient Examination
Glove, Disposable, single
use only and non-sterile | Similar | |
| Device Materials | Vinyl and oil-based liquid
Nitrile compound
The plasticizer type used is
different. | Vinyl and oil-based liquid
Nitrile compound
The plasticizer type used is
different. | Similar | |
| Color | Blue | Blue | Similar | |
| Characteristics | Stated
Standard | Device Performance | | Result of
comparison |
| | | Predicate device
K061562 | Subject Device
K142409 | |
| Tensile strength:
before and after
aging | K061562:
9Mpa min
K142409
11Mpa min | Before aging:14 MPa
After aging:14MPa | Before aging:
15.2Mpa
After aging:
14.6Mpa | Similar &
Both meet
ASTM
D5250
standard |
evice tolerances and specifications & Performance Data:
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Donggao Industrial Zone Zanhuang, Hebei, China 050000
K142409
| Characteristics | Stated
Standard | Device Performance | | Result of
comparison |
|------------------------------------------------------|-----------------------------------|------------------------------------------------------|------------------------------------------------------|-----------------------------------------------------|
| | | Predicate device
K061562 | Subject Device
K142409 | |
| Ultimate
elongation:
before and after
aging | 300% min | Before aging: 400%
After aging:300% | Before aging: 390%
After aging: 360% | Similar &
Both meet
ASTM
D5250
standard |
| Freedom from
pinholes | G-I,
AQL2.5 | G-I, AQL2.5 | G-I, AQL1.5 | Similar &
Both meet
ASTM
D5250
standard |
| Overall length | 230 for all
sizes min | 245mm | 239mm | |
| Width | S: 85±5 | 82 mm | 87 mm | Similar &
Both meet
ASTM
D5250
standard |
| | M: 95±5 | 97mm | 97 mm | |
| | L: 105±5 | 110mm | 107 mm | |
| | XL: 115±5 | 120mm | 118 mm | |
| Palm thickness | min0.08mm | 0.10mm | 0.08mm | |
| Finger thickness | min0.05mm | 0.10mm | 0.10mm | |
| Residual powder | Not more
than 2mg
per glove | Not more than 2mg
per glove | Not more than 2mg
per glove | Similar &
Both meet
ASTM
D5250
standard |
| Biocompatibility | | | | |
| Primary skin
irritation test | ISO 10993-
10 | Under conditions of
the study, not an
irritant | Under conditions of
the study, not an
irritant | Similar |
| Dermal
sensitization assay | ISO 10993-
10 | Under conditions of
the study, not an
irritant | Under conditions of
the study, not an
irritant | Similar |
The two versions of standards referenced for predicate device and subject device are compared in the following table:
| Testing Items | ASTM D5250-00ε 4
for Predicate device
K061562 | ASTM D 5250-06(2011)
for Subject Device
K142409 | Inspection
level | Result of
comparison |
|----------------|-----------------------------------------------------|-------------------------------------------------------|---------------------|-------------------------|
| Overall Length | 230 for all sizes min | 230 for all sizes mini | S-2, AQL4.0 | Same |
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Donggao Industrial Zone Zanhuang, Hebei, China 050000
K142409
| (mm) | ||||
|---|---|---|---|---|
| Width | ||||
| (mm) | S: 85±5 | S: 85±5 | S-2, AQL4.0 | Same |
| M: 95±5 | M: 95±5 | |||
| L: 105±5 | L: 105±5 | |||
| XL: 115±5 | XL: 115±5 | |||
| Palm Thickness | ||||
| (mm) | 0.08mm min | 0.08mm min | S-2, AQL4.0 | Same |
| Finger | ||||
| Thickness (mm) | 0.05mm min | 0.05mm min | S-2, AQL4.0 | Same |
| Tensile Before | ||||
| aging | 9Mpa min | 11Mpa min | Exceed | |
| Tensile After | ||||
| aging | 9Mpa min | 11Mpa min | S-2, AQL4.0 | Exceed |
| Elongation | ||||
| Before aging | 300% min | 300% min | Same | |
| Elongation After | ||||
| aging | 300% min | 300% min | S-2, AQL4.0 | Same |
| Pinhole | AQL 2.5 | AQL 2.5 | G-I | Same |
| Residual | ||||
| Powder | Not more than 2mg | |||
| per glove | Not more than 2mg per | |||
| glove | N=5 | Same |
Grand Work Plastic Products Co., Ltd. 's Vinyl Co-Polymer Powder Free Examination Gloves, Blue Color shares the same or comparable technology characteristics compared to the predicate device. The subject device performs according to the glove performance standards ASTM D5250-06(2011), biocompatibility requirement and FDA requirements and the labeling claims for the product. It performs as well as the legally marketed predicate device.
7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence is as Follows:
| Testing Items | FDA-recognized
Standard
Requirements | Inspection Level
and AQL | Testing Results | Conclusion |
|------------------------|--------------------------------------------|-----------------------------|-----------------|------------|
| Overall Length
(mm) | 230 for all sizes
min | S-2, AQL4.0 | 239mm | Pass |
| Width
(mm) | S: 85±5 | S-2, AQL4.0 | S: 87 | Pass |
| | M: 95±5 | | M: 97 | |
| | L: 105±5 | | L: 107 | |
| | XL: 115±5 | | XL: 118 | |
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Donggao Industrial Zone Zanhuang, Hebei, China 050000
K142409
| Palm Thickness
| (mm) | 0.08mm min | S-2, AQL4.0 | 0.08mm | Pass |
|---|---|---|---|---|
| Finger Thickness | ||||
| (mm) | 0.05mm min | S-2, AQL4.0 | 0.10mm | Pass |
| Tensile Strength (Mpa) | ||||
| Before aging | 11Mpa min | S-2, AQL4.0 | 15.2Mpa min | Pass |
| After aging | 11Mpa min | S-2, AQL4.0 | 14.6Mpa min | Pass |
| Ultimate Elongation (%) | ||||
| Before aging | 300% min | S-2, AQL4.0 | 390% min | Pass |
| After aging | 300% min | S-2, AQL4.0 | 360% min | Pass |
| Pinhole | 2.5 | G-I | AQL1.5 | Pass |
| Residual Powder | Not more than 2mg | |||
| per glove | N=5 | Not more than 2mg | ||
| per glove | Pass | |||
| (a) Primary Skin | ||||
| Irritation Test | Under conditions of the study, not an | |||
| irritant | Under conditions of the study, not an | |||
| irritant | ||||
| (b) Dermal | ||||
| Sensitization | ||||
| Study | Under conditions of the study, not an | |||
| irritant | Under conditions of the study, not an | |||
| irritant |
8. Discussion of Clinical Tests Performed:
Not Applicable
9. Labeling:
It is Patient Examination Glove, Disposable, single use only and non-sterile There are no special labeling claims.
10. Conclusions:
Grand Work Plastic Products Co., Ltd's Vinyl Co-Polymer Powder Free Examination Gloves, Blue Color conform fully to ASTM D 5250-06 ( 2011 ) standard as well as applicable 21 CFR references, and meets pinhole FDA requirements, biocompatibility requirements and labeling claims as shown by data discussed above. There are no safety/efficacy issues or new claims from the "substantial equivalence" products cited.
Drawn from the complete list of non-clinical tests, the device herein mentioned is as safe, as effective, and performs as well as the legally marketed predicate device.