(50 days)
LYY
Not Found
No
The device is a standard medical glove and the summary provides no indication of AI/ML technology.
No
Explanation: This device is a medical glove intended to prevent contamination, not to treat or cure a disease or condition.
No
Explanation: This device is a medical glove, which is used to prevent contamination. Its function is not to detect, diagnose, or monitor a disease or condition. The provided information describes its physical properties and performance characteristics as a barrier, not its diagnostic capabilities.
No
The device description clearly states it is a Class 1 Latex Patient Examination Glove, which is a physical hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the glove is for preventing contamination between healthcare personnel and the patient. This is a barrier function, not a diagnostic function performed in vitro (outside the body).
- Device Description: It's described as a "Latex Patient Examination Glove," which is a physical barrier device.
- Lack of Diagnostic Elements: The description and performance data focus on physical properties, barrier integrity (watertightness), and biocompatibility. There are no mentions of analyzing samples, detecting substances, or providing diagnostic information.
- No Mention of IVD-Specific Activities: The document does not mention any activities related to collecting, preparing, or analyzing biological samples for diagnostic purposes.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This glove does not perform any of those functions.
N/A
Intended Use / Indications for Use
This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
Product codes
LYY
Device Description
Class 1 Latex Patient Examination Glove 80 LYY, powder free that meets all the requirements of ASTM Standard D3578-01 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
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care 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 D3578-01 and FDA 1000ML watertight test.
Key results show the gloves meet:
- ASTM D3578-01 Standard
- FDA pinhole requirements
- FDA minimum Powder Residual Content.
- Label Claim of maximum 50 micrograms per gram of glove or less for water Extractable Protein.
Also, 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.)
| TEST | ASTM D3578-01 | POWDER FREE LATEX 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 0.08 Min 0.08 | Min 0.10 Min 0.10 |
| 5. Physical Properties Before Aging Tensile Strength (MPa) Ultimate Elongation (%) Stress at 500% Elongation After Aging Tensile Strength (MPa) Ultimate Elongation (%) | Min 18 Min 650 Max 5.5 Min 14 Min 500 | 23 - 25 800-860 2.1-2.7 22 - 24 800 - 860 |
| 6. Powder Content | Max 2.0mg/glove | Below 2 mg/glove |
| 7. Protein Content | Max 50 microgram/gram | Below 50 microgram/gram |
Predicate Device(s)
Class 1 Latex Patient Examination Glove 80 LYY
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/0 description: The image shows a black and white graphic of an abstract design. The design features a horizontal curved shape at the top, resembling a crescent or an arch. Below this curved shape, there are several rectangular and square shapes arranged in a symmetrical pattern, giving the impression of a stylized structure or symbol. The overall composition is simple and geometric, with a focus on the contrast between the black shapes and the white background.
TY INDUSTRY (MANJUNG) SDN. BHD.
Company No : 380830-P) 1422-1424, Batu 10 Lekir, 32020 Sitiawan, Perak Darul Ridzuan, Malaysia. Tel : 05-6792288 (Hunting Line), 6792443 & 6792445 Fax : 05-6791188
MAR 0 7 2003
APPENDIX-K
SMDA 510 (K) SUMMARY 1.0 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 December 20, 2002 Date of Summary Prepared
3.0 Name of Device
Trade Name: NON-STERILE, POWDER-FREE, POLYMER COATED, NATURAL AND/OR VIOLET AND BLACK COLOR, LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM
Common Name Exam Glove
Classification Name Patient Examination Glove
4.0 Identification of The Legally Marketed Devices
Class 1 Latex Patient Examination Glove 80 LYY, powder free that meets all the requirements of ASTM Standard D3578-01 and FDA requirements.
5.0 Description of The Device
Class 1 Latex Patient Examination Glove 80 LYY, powder free that meets all the requirements of ASTM Standard D3578-01 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, waste or environment.
1
Summary of Performance Data: 7.0
Performance data of gloves based on ASTM D3578-01 and FDA 1000ML watertight test.
| TEST | ASTM D3578-01 | POWDER FREE LATEX 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 0.08
Min 0.08 | Min 0.10
Min 0.10 |
| 5. Physical Properties
Before Aging
Tensile Strength (MPa)
Ultimate Elongation (%)
Stress at 500% Elongation
After Aging
Tensile Strength (MPa)
Ultimate Elongation (%) | Min 18
Min 650
Max 5.5
Min 14
Min 500 | 23 - 25
800-860
2.1-2.7
22 - 24
800 - 860 |
| 6. Powder Content | Max 2.0mg/glove | Below 2 mg/glove |
| 7. Protein Content | Max 50 microgram/gram | Below 50 microgram/gram |
2
- 8.0 The performance data of the glove as shown above meet the ASTM D3578-01 Standard and FDA's requirement. Powder content is below 2 mg per glove which meet the FDA Requirements. The protein content tested on accelerated aging gloves is ≤ 50 mg/gram.
- 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, Powder Free Natural or Colored Latex Examination Gloves with Protein claim of ≤ 50 micrograms per gram meets:
- ASTM D3578-01 Standard -
- FDA pinhole requirements -
- FDA minimum Powder Residual Content. -
- Label Claim of maximum 50 micrograms per gram of glove or less for water ﺴ Extractable Protein.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 a stylized image of three human profiles facing right, with flowing lines above them that resemble a bird in flight.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 0 7 2003
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: K030164
Trade/Device Name: Multiple Private Labeled, Non-Sterile, Powder-Free, Polymer Coated, Natural and/or Violet and Black Color, Latex Examination Gloves with Protein Labeling Contains 50 Micrograms or Less of Total Water Extractable Protein Per Gram Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: January 15, 2003 Received: January 16, 2003
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.
4
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 (301) 594-4613. 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/dsma/dsmamain.html
Sincerely yours,
Susan Puaser
Susan Runner, DDS, MA · Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATION FOR USE STAT
YTY INDUSTRY (MANJUNG) SDN BHD Applicant:
510K Number:
- Device Name: MULTIPLE PRIVATE LABELED, NON-STERILE, POWDER-FREE, POLYMER COATED, NATURAL AND/OR VIOLET AND BLACK COLOR, LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEN PER GRAM
Indications for Use:
This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
Concurrence of CDRH Office of Device Evaluation (ODE)
Prescription Use.....................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................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........................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................... be like.
Division of Anesthesiology, General Hospital Infection Control, Dental De
510(k) Number. K030164