(66 days)
Not Found
Not Found
No
The 510(k) summary describes a standard examination glove and does not mention any AI or ML capabilities. The performance data relates to physical properties and watertightness, not algorithmic performance.
No.
The device is described as a glove intended to prevent contamination, not to provide therapy or treatment.
No
The "Intended Use" states the device is to prevent contamination, and the "Device Description" identifies it as a Class 1 Nitrile Patient Examination Glove. There is no indication that it is used for diagnosis or detection of diseases.
No
The device is a physical examination glove, which is a hardware medical device, not software. The summary describes physical properties and performance tests related to the material and construction of the glove.
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 barrier worn on the hand or finger to prevent contamination between patient and examiner. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: It's described as a Class 1 Nitrile Patient Examination Glove. Gloves are considered medical devices, but not IVDs.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.) or to provide information about a patient's health status or condition.
- Performance Data: The performance data focuses on physical properties (watertightness, dimensions, strength, elongation) and biocompatibility, which are relevant to a barrier device, not a diagnostic test.
IVD devices are specifically designed to perform tests on samples from the human body to provide information for diagnosis, monitoring, or screening. This glove does not fit that description.
N/A
Intended Use / Indications for Use
The Non-Sterile, Powder-Free Nitrile Blue & White 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.
Product codes (comma separated list FDA assigned to the subject device)
LZA
Device Description
Class 1 Nitrile Patient Examination Glove 80 LZA, powder free that meets all the requirements of ASTM Standard D6319-00a83 and FDA Water leak test.
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
healthcare and similar personnel
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 D6319-00a8 and FDA 1000ML watertight test.
TEST: Watertight (1000ml)
ASTM D6319-00a3: Multiple Normal GI AQL = 2.5
ON-LINE POWDER FREE NITRILE EXAM. GLOVES: Pass GI, AQL = 2.5
TEST: Length (mm)
Size XS: Min 220
Size S: Min 220
Size M: Min 230
Size L: Min 230
ON-LINE POWDER FREE NITRILE EXAM. GLOVES: 240 mm minimum for all sizes
TEST: Palm width (mm)
Size XS: 70 ± 10
Size S: 80 ± 10
Size M: 95 ± 10
Size L: 111 ± 10
ON-LINE POWDER FREE NITRILE EXAM. GLOVES: XS 73 - 78, S 83 - 88, M 93 - 98, L 103 - 107
TEST: Thickness (mm) (Single Layer)
Finger: Min 0.05
Palm: Min 0.05
ON-LINE POWDER FREE NITRILE EXAM. GLOVES: Finger Min 0.15, Palm Min 0.12
TEST: Physical Properties Before Aging
Tensile Strength (MPa): Min 14
Ultimate Elongation (%): Min 500
ON-LINE POWDER FREE NITRILE EXAM. GLOVES: Tensile Strength (MPa) 27 - 30, Ultimate Elongation (%) 780 - 800
TEST: Physical Properties After Aging
Tensile Strength (MPa): Min 14
Ultimate Elongation (%): Min 400
ON-LINE POWDER FREE NITRILE EXAM. GLOVES: Tensile Strength (MPa) 25 - 27, Ultimate Elongation (%) 670 - 730
TEST: Powder Content
Max 2.0mg/glove
ON-LINE POWDER FREE NITRILE EXAM. GLOVES: Below 2 mg/glove
The performance data of the glove as shown above meet the ASTM D6319-00a83 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 Sensitization (Buehler) test. The gloves pass the Bio-compatibility Test.
Conclusion: The Multiple Private Labeled Non-Sterile, On-Line Powder Free Nitrile Blue & White Color Examination Gloves meets: ASTM D6319-00a63Standard, FDA pinhole requirements, and are below the maximum Powder Residual Content as specified in ASTM -D6319-00a83.
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.
Not Found
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
INDUSTRY (MANJUNG) SDN. BHD.
ompany No : 380830-P) ot 1422-1424, Batu 10 Lekir, 32020 Sitiawan, Perak Darul Ridzuan, Malaysia.
Ot 1422-1424, Batu 10 Lekir, 32020 Sitiawan, Perak Darul Ridzuan, Malaysia. Lot 1422-1424, Bata 10 Lokii, Cel 6792443 & 6792445 - Fax : 05-6791188
| NOV | 1 8 2005 |
|---|---|
| ----- | ---------- |
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 | July 20, 2005 |
3.0 Name of Device
Trade Name: NON-STERILE, ON-LINE POWDER-FREE, NITRILE BLUE & WHITE COLOR, EXAMINATION GLOVES
| Common Name | Exam Glove |
|---|---|
| ------------- | ------------ |
Classification Name Patient Examination Glove
4.0 Identification of The Legally Marketed Devices
Class 1 Nitrile Patient Examination Glove 80 LZA, powder free that meets all the requirements of ASTM Standard D6319-00a63 and FDA requirements.
5.0 Description of The Device
Class 1 Nitrile Patient Examination Glove 80 LZA, powder free that meets all the requirements of ASTM Standard D6319-00a83 and FDA Water leak test.
6.0 The Intended Use of Glove
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, ware or environment.
1
KOS2502
Summary of Performance Data: 7.0
Performance data of gloves based on ASTM D6319-00a8 and FDA 1000ML watertight test.
| TEST | ASTM D6319-00a3 | ON-LINE POWDER FREE
NITRILE EXAM. GLOVES | |
|-------------------------------------------------------------------|------------------------------------------------------------------|---------------------------------------------|----------------------|
| 1. Watertight (1000ml) | Multiple Normal
GI AQL = 2.5 | Pass GI | 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 ± 10
80 ± 10
95 ± 10
111 ± 10
-
| 73 - 78
83 - 88
93 - 98
103 - 107 | |
| 4. Thickness (mm)
(Single Layer) | | | |
| Finger
Palm | Min 0.05
Min 0.05 | Min 0.15
Min 0.12 | |
| 5. Physical Properties | | | |
| Before Aging
Tensile Strength (MPa)
Ultimate Elongation (%) | Min 14
Min 500 | | 27 - 30
780 - 800 |
| After Aging
Tensile Strength (MPa)
Ultimate Elongation (%) | Min 14
Min 400 | | 25 - 27
670 - 730 |
| 6. Powder Content | Max 2.0mg/glove | Below 2 mg/glove | |
2
- 8.0 The performance data of the glove as shown above meet the ASTM D6319-00a83 Standard and FDA's requirement. Powder content is below 2 mg per glove which meet the FDA Requirements.
- 9.0 The Bio-compatibility Test consists of Primary Dermal Irritation Test and Guinea Pig Sensitization (Buehler) test. The gloves pass the Bio-compatibility Test.
- 10.0 Conclusion
We concluded that the Multiple Private Labeled Non-Sterile, On-Line Powder Free Nitrile Blue & White Color Examination Gloves meets:
- ASTM D6319-00a63Standard -
- FDA pinhole requirements -
- Are below the maximum Powder Residual Content as specified in ASTM -D6319-00a83
3
K 052502
angle programment of the comments of the program of the program and the program of the program and the comments of the section of the section of the section of the section of
11 11 11
Appendix J 510(k) Summary Sheet
.. 합니다. .. .. ..
이 관한 사람들이 아니라 그 이 관
| Description and Intended Use of the Gloves........................ | Appendix J, Page 1 |
|---|---|
| Product Comparison Chart against ASTM D6319- | |
| 00aε3 and FDA 1000ML Watertight test | |
| Standards........................ | Appendix J, Page 2 |
4
Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The bird is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a sans-serif font. The text is arranged around the circumference of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 8 2005
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: K052502
Trade/Device Name: Non-Sterile, Powder-Free Nitrile Blue & White Examination Gloves Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: November 10, 2005 Received: November 14, 2005
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 (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.
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Auey Suleom for
Chin-Lin, Ph.D.
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
6
INDICATIONS FOR USE
APPLICANT: YTY INDUSTRY (MANJUNG)
SDN. BHD.
510(k) NUMBER: R052502
DEVICE NAME: NON-STERILE, POWDER-FREE NITRILE
BLUE & WHITE EXAMINATION GLOVES
Indications For Use:
The Non-Sterile, Powder-Free Nitrile Blue & White 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.
Prescription Use ... ................... Per 21 CFR 801.109
AND/OR
Over-The-Counter Use ... ... ... .......... (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 H. Murphy, KS
on Sign-On)
of Anesthesiology, General Hospital, on Control, Dental Devices