(42 days)
Not Found
No
The device is a disposable examination glove, and the summary focuses on material properties and performance standards, with no mention of AI/ML.
No.
The device (examination glove) is intended to prevent contamination between patient and examiner, not to provide therapy or treatment for a disease or condition.
No
The device, a nitrile examination glove, is intended for preventing contamination, not for diagnosing a condition or disease.
No
The device is a physical examination glove made of nitrile, not software. 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 Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Intended Use: The intended use of this device 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 on the body, not for testing specimens from the body.
- Lack of IVD Characteristics: The description and performance data focus on the physical properties and barrier function of the glove (watertightness, tensile strength, elongation, powder content, biocompatibility). There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on testing specimens.
This device is a medical glove, which is a Class I or Class II medical device depending on its intended use and risk, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.
This Non-Sterile, Powder-Free, Black Nitrile 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.
Product codes
LZA
Device Description
Black Colour Powder Free Nitirle Examination Gloves meets all the current specifications listed under the ASTM Specification D6319-00ar Standard Specification for Nitrile Examination 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 fingers
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner
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)
Performance data of gloves based on ASTM D6319-00a and FDA 1000ML watertight test.
TEST: Watertight (1000ml), ASTM D6319-00a Parameters: Multiple Normal GII AQL = 2.5, POWDER FREE NITRILE EXAMINATION GLOVES Results: Pass GII AQL = 2.5.
TEST: Length (mm), Size XS, S, M, L, XL, ASTM D6319-00a Parameters: Min 220 for XS, S Min 230 for M, L, POWDER FREE NITRILE EXAMINATION GLOVES Results: 240 mm minimum for all sizes.
TEST: Palm width (mm), Size XS, S, M, L, XL, ASTM D6319-00a Parameters: 70 +/- 10 for XS, 80 +/- 10 for S, 95 +/- 10 for M, 111 +/- 10 for L, POWDER FREE NITRILE EXAMINATION GLOVES Results: 73 - 78 for XS, 83 - 88 for S, 93 - 98 for M, 103 - 107 for L.
TEST: Thickness (mm) (Single Layer), Finger, Palm, ASTM D6319-00a Parameters: Min 0.05 for Finger and Palm, POWDER FREE NITRILE EXAMINATION GLOVES Results: Min 0.08 for Finger and Palm.
TEST: Physical Properties, Before Aging: Tensile Strength (MPa), Ultimate Elongation (%), After Aging: Tensile Strength (MPa), Ultimate Elongation (%), ASTM D6319-00a Parameters: Min 14 for Tensile Strength (MPa) Before Aging, Min 500 for Ultimate Elongation (%) Before Aging, Min 14 for Tensile Strength (MPa) After Aging, Min 400 for Ultimate Elongation (%) After Aging, POWDER FREE NITRILE EXAMINATION GLOVES Results: 15 - 21 for Tensile Strength (MPa) Before Aging, 550 - 630 for Ultimate Elongation (%) Before Aging, 14 - 22 for Tensile Strength (MPa) After Aging, 520 - 610 for Ultimate Elongation (%) After Aging.
TEST: Powder Content, ASTM D6319-00a Parameters: Max 2.0mg/glove, POWDER FREE NITRILE EXAMINATION GLOVES Results: Below 2 mg/glove.
The Bio-compatibility Test consists of Primary Dermal Irritation Test and Guinea Pig Sensitization (Buehler) test. The gloves pass the Bio-compatibility Test.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
and the comments of the comments of the comments of
:
:
JUL 1 7 2006
Appendix J 510(k) Summary Sheet
:
:
:
| Description and Intended Use of the Gloves........................ | Appendix J, Page 1 |
|---|---|
| Product Comparison Chart against ASTM D6319-00ae3 | |
| and FDA 1000ML Watertight test Standards........................ | Appendix J, Page 2 |
.
1
Image /page/1/Picture/0 description: The image shows a black and white drawing of a symbol. The symbol is composed of a horizontal curved line at the top, resembling a crescent. Below the curved line, there are two vertical rectangular shapes, with smaller horizontal rectangular shapes on either side of the top rectangular shape. The symbol appears to be abstract and stylized.
YTY INDUSTRY (MANJUNG) SDN. BHD.
(Company No : 380830-P) Lot 1422-1424, Batu 10 Lekir, 32020 Sitiawan, Perak Darul Ridzuan, Malaysia. Tel : 05-6792288 (Hunting Line), 6792443 & 6792445 Fax : 05-6791188
APPENDIX-J
| 1.0 | SMDA 510 (K) SUMMARY | ||
|---|---|---|---|
| 2.0 | Submitter | YTY Industry (Manjung) Sdn Bhd | |
| Lot 1422-1424, Batu 10 Lekir | |||
| 32020 Sitiawan | |||
| Perak Darul Ridzuan | |||
| MALAYSIA | |||
| Tel | 605-6792288 | ||
| Fax | 605-6791188 | ||
| Name of Contact Person | 1. MR. MOH UNG NANG | ||
| Official Correspondence | 2. MS. JANNA TUCKER | ||
| Date of Summary Prepared | May 2, 2006 | ||
| 3.0 | Name of Device | ||
| Trade Name: | Non-Sterile, Powder-Free, Black Nitrile Examination Gloves. | ||
| Common Name: | Synthetic Rubber Examination Gloves |
Classification Name: Patient Examination Glove, Powder Free
4.0 Identification of The Legally Marketed Devices
Black Colour Powder Free Nitirle Examination Gloves as described in this 510k Notification is substantially equivalent to the current Class I patient examination glove bearing the product code 80LZA (21CFR 880,6250). It meets all the current specifications listed under the ASTM Specification D6319-00at Standard Specification for Nitrile Gloves for Medical Application.
EQui VALENT TO KOST 50Z EXCEPT FOR COLOR.
5.0 Description of The Device
.
Black Colour Powder Free Nitirle Examination Gloves meets all the current specifications listed under the ASTM Specification D6319-00ar Standard Specification for Nitrile Examination Gloves for Medical Application.
2
6.0 The Intended Use of Glove
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.
7.0 Summary of Performance Data:
Performance data of gloves based on ASTM D6319-00a and FDA 1000ML watertight test.
| TEST | ASTM D6319-00a $$ | POWDER FREE NITRILE EXAMINATION GLOVES |
|---|---|---|
| 1. Watertight (1000ml) | Multiple Normal | |
| GII | ||
| AQL = 2.5 | Pass GII | |
| AQL = 2.5 | ||
| 2. Length (mm) | ||
| Size XS | ||
| S | ||
| M | ||
| L | ||
| XL | Min 220 | |
| Min 220 | ||
| Min 230 | ||
| Min 230 |
-
| 240 mm minimum for all sizes |
| 3. Palm width (mm)
Size XS
S
M
L
XL | $70 \pm 10$
$80 \pm 10$
$95 \pm 10$
$111 \pm 10$
- | 73 - 78
83 - 88
93 - 98
103 - 107 |
| 4. Thickness (mm)
(Single Layer)
Finger
Palm | Min 0.05
Min 0.05 | Min 0.08
Min 0.08 |
| 5. Physical Properties
Before Aging
Tensile Strength (MPa)
Ultimate Elongation (%)
After Aging
Tensile Strength (MPa)
Ultimate Elongation (%) | Min 14
Min 500
Min 14
Min 400 | 15 - 21
550 - 630
14 - 22
520 - 610 |
| 6. Powder Content | Max 2.0mg/glove | Below 2 mg/glove |
3
- 8.0 The performance data of the glove as shown above meet the ASTM D6319-00a E-3 Standard and FDA's requirement. Powder content is below 2 mg per glove which meet the FDA Requirements.
- The Bio-compatibility Test consists of Primary Dermal Irritation Test and Guinea Pig 9.0 Sensitization (Buehler) test. The gloves pass the Bio-compatibility Test.
- 10.0 Conclusion
We conclude that the Multiple Private Labeled Non-Sterile Black Colour Powder Free Nitirle Examination Gloves meets:
- -ASTM D6319-00a Standard
- -FDA pinhole requirements
- Are below the maximum Powder Residual Content as specified in ASTM -D6319-00aE3
4
Image /page/4/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name arranged in a circular pattern around a stylized emblem. The emblem consists of a stylized caduceus, a symbol often associated with healthcare, representing the department's focus on health and well-being. The seal is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 7 2006
YTY Industry (Manjung) Sdn. Bhd. C/O Ms. Janna P. Tucker Official Correspondent Tucker & Associates 198 Avenue De La D'Emerald Sparks, Nevada 89434-9550
Re: K061553
Trade/Device Name: Non-Sterile, Powder-Free, Black Nitrile Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: June 1, 2006 Received: June 7, 2006
Dear Ms. Tucker:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to such 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 - Ms. Tucker
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sutta Y. Michaud
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
INDICATIONS FOR USE
| APPLICANT: | YTY INDUSTRY (MANJUNG) SDN.
BHD. |
|----------------|--------------------------------------------------------------|
| 510(k) NUMBER: | |
| DEVICE NAME: | NON-STERILE, POWDER-FREE, BLACK NITRILE
EXAMINATION GLOVE |
Indications For Use:
This Non-Sterile, Powder-Free, Black Nitrile 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.
Prescription Use....................... Per 21 CFR 801.109
AND/OR
Over-The-Counter Use ... X .......... (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shule K. Mupadhyay, M.D. 2/14/04
n of Anesthesiology, General Hospital, on Control, Dental Devices
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