(97 days)
Not Found
No
The device is a simple examination glove and the description focuses on material properties and performance standards, with no mention of AI or ML.
No.
The device is a patient examination glove, intended to prevent contamination between patient and examiner, and does not provide therapeutic benefits.
No
The device description indicates that it is a patient examination glove used to prevent contamination, not to diagnose a medical condition.
No
The device is a physical examination glove made of vinyl, not a software application. The description focuses on material properties and physical performance tests.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided text clearly states the device is a "patient examination glove" intended to be worn on the hand or finger to prevent contamination between patient and examiner. This is a physical barrier device used during a medical examination, not a device that analyzes biological specimens.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, chemical reactions, or diagnostic information derived from patient specimens.
Therefore, based on the provided information, this device is a medical device, but it falls under a different category than In Vitro Diagnostics.
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
LYZ
Device Description
Powder Free Vinyl Patient Examination Gloves (Yellow, White, Blue, Pink) are Patient Examination Gloves, Disposable, single use only and non-sterile. The gloves are made of vinyl 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
Hand or finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Examiner / 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:
- Study Type: Performance testing based on ASTM D5250-06 (2011) and biocompatibility testing based on ISO 10993-10.
- Sample Size:
- Overall Length, Width, Palm Thickness, Finger Thickness, Tensile Strength, Ultimate Elongation: S-2, AQL4.0 (sample size not specified, but refers to general inspection level and acceptable quality limit).
- Pinhole: G-I (125 gloves sampled).
- Residual Powder: N=5.
- Primary Skin Irritation Test: Sample size not specified.
- Dermal Sensitization Study: Sample size not specified.
- Key Results:
- Overall Length: S: 232-245mm, M:233-241mm, L:236-243mm, XL: 234-242mm (Pass, minimum 230mm).
- Width: S: 87-88mm, M: 97-98mm, L: 107-108mm, XL: 118-119mm (Pass, within specified ranges).
- Palm Thickness: 0.08mm (Pass, minimum 0.08mm).
- Finger Thickness: 0.10-0.12mm (Pass, minimum 0.05mm).
- Tensile Strength (Before aging): 15.2-18.1Mpa (Pass, minimum 11Mpa).
- Tensile Strength (After aging): 14.6-17.4Mpa (Pass, minimum 11Mpa).
- Ultimate Elongation (Before aging): 390-470% (Pass, minimum 300%).
- Ultimate Elongation (After aging): 360-450% (Pass, minimum 300%).
- Pinhole: 0 piece leaks out of 125 gloves sampled, meets AQL2.5 requirements (Pass).
- Residual Powder: 0.16mg (Pass, not more than 2mg per glove).
- Primary Skin Irritation Test: Not an irritant (Pass).
- Dermal Sensitization Study: Not an irritant (Pass).
- Conclusion: The device is as safe, as effective, and performs as well as the legally marketed predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Tensile strength:
- Before aging: 15.2-18.1Mpa
- After aging: 14.6-17.4Mpa
- Ultimate elongation:
- Before aging: 390-470%
- After aging: 360-450%
- Freedom from pinholes: 125 glove sampled and 0 piece leaks
- Dimensions:
- Length: 232-245mm
- Width: S/87, M/97, L/107, XL/118
- Palm Thickness: 0.08-0.10mm
- Finger Thickness: 0.10-0.12mm
- Residual powder: 0.16 mg/glove
Predicate Device(s)
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
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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure, represented by three overlapping profiles, suggesting a sense of community and care. The logo is presented in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 18, 2014
Ever Light Plastic Products Company, Ltd. C/O Ms. Kathy Liu Project Manager Hongray USA Medical Products, Inc. 3973 Schaefer Avenue Chino, CA 91710
Re: K142570
Trade/Device Name: Powder Free Vinyl Patient Examination Gloves (Yellow, White, Blue, Pink) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: October 22, 2014 Received: October 28, 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,
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
2
Indications for Use
510(k) Number (if known) K142570
Device Name
Powder Free Vinyl Patient Examination Gloves (Yellow, White, Blue, Pink)
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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3
Donggao Industrial Zone Zanhuang, Shijiazhuang, Hebei, China 050000
Product: Powder Free Vinyl Patient Examination Gloves (Yellow, White, Blue, Pink)
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:
1. Owner's Identification :
Mr. Zhang Litao Ever Light Plastic Products Co., Ltd. Donggao Industrial Zone Zanhuang, Shijiazhuang, Hebei, China 050000
Tel: 86-311-83601854 Fax: 86-311-83616934
Contact: Ms. Kathy Liu, Project Manager Address: 3973 Schaefer Ave., Chino, CA 91710 Tel: 909-590-1611 Fax: 909-590-1511 Date Summary Prepared: September 9, 2014
2. Name of the Device:
Trade Name: Powder Free Vinyl Patient Examination Gloves (Yellow, White, Blue, Pink) Common Name: Exam Gloves Classification Name: Patient Examination Glove Classification Regulation: 880.6250 Classification Panel: 880 General Hospital and Personal Use Product Code: LYZ Device Class: Class I
3. Predicate Device Information:
Hongze Plastic Technology Co., Ltd. Powder Free Vinyl Patient Examination Gloves, (Yellow, White, Blue, Pink) (K101135)
4. Device Description:
Powder Free Vinyl Patient Examination Gloves (Yellow, White, Blue, Pink) are Patient Examination Gloves, Disposable, single use only and non-sterile. The gloves are made of vinyl materials and are powder free. The physical and performance characteristics of the devices meet all requirements of ASTM D5250-06
4
Donggao Industrial Zone Zanhuang, Shijiazhuang, Hebei, China 050000
Product: Powder Free Vinyl Patient Examination Gloves (Yellow, White, Blue, Pink)
(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.
6. Technological Characteristics and Substantial Equivalence:
Ever Light Plastic Products Co., Ltd.'s Powder Free Vinyl Patient Examination Gloves (Yellow, White, Blue, Pink) is substantially equivalent in safety and effectiveness to the Hongze Plastic Technology Co., Ltd.'s Powder Free Vinyl Patient Examination Gloves, (Yellow, White, Blue, Pink) (K 101135). 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 | Standard | Device Performance | | Result of
comparison |
|--------------------------------------------------------------------------------|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| | | Predicate device | Subject Device | |
| Product Code | / | LYZ | LYZ | Similar |
| Intended 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 | / | There are no special
labeling claims and
do not claim gloves
as hypoallergenic on
labels. | There are no special
labeling claims and
do not claim gloves
as hypoallergenic on
labels. | Similar |
| Device Materials | / | Vinyl | Vinyl | Similar |
| Color | / | Yellow White Blue
Pink | Yellow White Blue
Pink | Similar |
| Device tolerances and specifications & Performance Data: | | | | |
| Characteristics | Standard | Device Performance | | Result of
comparison |
| Tensile strength:
before and after
aging | ASTM
D 5250-06
(2011) | Before aging:
14.3-17.6MPa
After aging:
13.3-16.8Mpa | Before aging:
15.2-18.1Mpa
After aging:
14.6-17.4Mpa | Similar |
| Ultimate
elongation:
before and after
aging | ASTM
D 5250-06
(2011) | Before aging:
380-429%
After aging:
370-401% | Before aging:
390-470%
After aging:
360-450% | Similar |
| Freedom from
pinholes | ASTM
D 5250-06
(2011) | G-I, AQL2.5
125 glove sampled
and 1 piece leaks | G-I, AQL2.5
125 glove sampled
and 0 piece leaks | Similar |
| Dimensions:
Overall
length,
Width, Palm
and
Finger
thickness | ASTM
D 5250-06
(2011) | Length:245-246mm
Width: S/86, M/96,
L/106, XL/116
Palm Thickness:
0.08-0.10mm
Finger Thickness:
0.10-0.11mm | Length:232-245mm
Width: S/87, M/97,
L/107, XL/118
Palm Thickness:
0.08-0.10mm
Finger Thickness:
0.10-0.12mm | Similar |
| Residual powder | ASTM
D 5250-06
(2011) | 0.9mg/glove | 0.16 mg/glove | Similar |
| 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 |
| 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 | 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 | Similar |
| Characteristics | Standard | Device Performance | | Result of comparison |
| | | Predicate device | Subject Device | |
| | | between patient and examiner. | examiner. | |
5
Donggao Industrial Zone Zanhuang, Shijiazhuang, Hebei, China 050000
Product: Powder Free Vinyl Patient Examination Gloves (Yellow, White, Blue, Pink)
6
Donggao Industrial Zone Zanhuang, Shijiazhuang, Hebei, China 050000
Product: Powder Free Vinyl Patient Examination Gloves (Yellow, White, Blue, Pink)
Ever Light Plastic Products Co., Ltd.'s Powder Free Vinyl Patient Examination Gloves (Yellow, White, Blue, Pink) 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 | Actual Testing
Results | Conclusion |
|-----------------------------|---------------------------------------------|-----------------------------|-------------------------------------------------------------|------------|
| Overall
Length
(mm) | 230 for all sizes
minimum | S-2, AQL4.0 | S: 232-245mm
M:233-241mm
L:236-243mm
XL: 234-242mm | Pass |
| Width
(mm) | S: 85±5
M: 95±5
L: 105±5
XL: 115±5 | S-2, AQL4.0 | 87-88 mm
97-98 mm
107-108 mm
118-119 mm | Pass |
| Palm
Thickness
(mm) | 0.08mm
minimum | S-2, AQL4.0 | 0.08mm | Pass |
| Finger
Thickness
(mm) | 0.05mm
minimum | S-2, AQL4.0 | 0.10-0.12mm | Pass |
| Tensile Strength (Mpa) | | | | |
| Before aging | 11Mpa minimum | S-2, AQL4.0 | 15.2-18.1Mpa | Pass |
| After aging | 11Mpa minimum | S-2, AQL4.0 | 14.6-17.4Mpa | Pass |
| Ultimate Elongation (%) | | | | |
| Before aging | 300% minimum | S-2, AQL4.0 | 390-470% | Pass |
| After aging | 300% minimum | S-2, AQL4.0 | 360-450% | Pass |
| Pinhole | 2.5 | G-I | 125 glove sampled
and 0 piece leaks,
meet AQL2.5 | Pass |
7
Donggao Industrial Zone Zanhuang, Shijiazhuang, Hebei, China 050000
Product: Powder Free Vinyl Patient Examination Gloves (Yellow, White, Blue, Pink)
| requirements | ||||
|---|---|---|---|---|
| Residual | ||||
| Powder | Not more than | |||
| 2mg per glove | N=5 | 0.16mg | 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 - There is no hypoallergenic Claim. There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. The substantial equivalence of the device is supported by the nonclinical testing.
9. Labeling:
We do not claim our gloves as hypoallergenic on our labels.
10. Conclusions:
Ever Light Plastic Products Co., Ltd's Powder Free Vinyl Patient Examination Gloves (Yellow, White, Blue, Pink) 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.