(14 days)
Not Found
No
The device is a standard examination glove and the summary contains no mention of AI, ML, or any related computational processing.
No
The device is a patient examination glove, which is intended to prevent contamination rather than treat a disease or condition.
No
Explanation: The device is a patient examination glove, described as preventing contamination between patient and examiner. Its function is protective, not diagnostic.
No
The device description clearly states it is a physical product (gloves) and the performance studies relate to physical properties and standards for gloves, not software.
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 "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 for infection control, not a device used to examine specimens derived from the human body for diagnostic purposes.
- Device Description: The description is "POWDERED NATURAL AND/OR COLORED LATEX EXAM GLOVES." This further reinforces its nature as a physical barrier.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting specific analytes or markers
- Providing diagnostic information about a patient's condition
- Using reagents or assays
The information provided focuses on the physical properties and performance of the glove as a barrier, which aligns with the regulatory requirements for medical gloves, not IVDs.
N/A
Intended Use / Indications for Use
A 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.
Product codes (comma separated list FDA assigned to the subject device)
LYY
Device Description
POWDERED NATURAL AND/OR COLORED LATEX EXAM GLOVES
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 professionals at Dentist and Doctor Offices, Laboratories, Clinics and Hospitals
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.
TEST: Watertight (1000ml)
ASTM D3578-01/AE2: Multiple Normal GI AQL = 2.5
EVERGREEN POWDERED LATEX EXAM. GLOVES: Pass GI AQL = 2.5
TEST: Length (mm) Size XS, S, M, L, XL
ASTM D3578-01/AE2: Min 220, Min 220, Min 230, Min 230, -
EVERGREEN POWDERED LATEX EXAM. GLOVES: 240 mm minimum for all sizes
TEST: Palm width (mm) Size XS, S, M, L, XL
ASTM D3578-01/AE2: 70 ± 10, 80 ± 10, 95 ± 10, 111 ± 10, -
EVERGREEN POWDERED LATEX EXAM. GLOVES: 73 - 78, 83 - 88, 93 - 98, 103 - 107
TEST: Thickness (mm) (Single Layer) Finger, Palm
ASTM D3578-01/AE2: Min 0.08, Min 0.08
EVERGREEN POWDERED LATEX EXAM. GLOVES: Min 0.10, Min 0.10
TEST: Physical Properties Before Aging Tensile Strength (MPa)
ASTM D3578-01/AE2: Min 18
EVERGREEN POWDERED LATEX EXAM. GLOVES: 23 - 27
TEST: Ultimate Elongation (%)
ASTM D3578-01/AE2: Min 650
EVERGREEN POWDERED LATEX EXAM. GLOVES: 820 - 880
TEST: Stress at 500% Elongation
ASTM D3578-01/AE2: Max 5.5
EVERGREEN POWDERED LATEX EXAM. GLOVES: 2.9-3.6
TEST: After Aging Tensile Strength (MPa)
ASTM D3578-01/AE2: Min 14
EVERGREEN POWDERED LATEX EXAM. GLOVES: 20 - 27
TEST: Ultimate Elongation (%)
ASTM D3578-01/AE2: Min 500
EVERGREEN POWDERED LATEX EXAM. GLOVES: 780 - 860
TEST: Powder Content
ASTM D3578-01/AE2: 10mg per square decimeter max
EVERGREEN POWDERED LATEX EXAM. GLOVES: Below 10 mg per square decimeter
This device has met or exceeded the following standards and/or tests: ASTM D 5712-99 ASTM D 3578-01aE2 ASTM D 6124-01 ASTM D 5151-99 ISO 2859
Bio-Compatibility: Dermal Sensitization Primary Skin Irritation
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
8 2002 NOV
| K023590 | |
|---|---|
| 510(k) SUMMARY | |
| Submitted For: | YTY INDUSTRY (MANJUNG) SDN BHD |
| Submitted By: | TUCKER & ASSOCIATES |
| Official Correspondent for YTY INDUSTRY | |
| (MANJUNG) SDN BHD | |
| JANNA P. TUCKER, President-CEO | |
| 198 Avenue de la D'emerald | |
| Sparks, NV 89434-9550 | |
| Phone: | 775-342-2612 |
| Fax: | 775-342-2613 |
| E-Mail: | Tuckerjan@aol.com |
| Date of Submission: | 23 October 2002 |
| Device Name: | POWDERED NATURAL AND/OR COLORED |
| LATEX EXAM GLOVES | |
| Class I Device, 80LYY | |
| Proprietary Name: | (Multiple Private Labels) |
| Labels/Labeling: | This device will be marketed to healthcare professionals at |
| Dentist and Doctor Offices, Laboratories, Clinics and | |
| Hospitals through its distributors for the intended use. | |
| Intended Use: | A 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. | |
| Substantial Equivalence: | Both in its intended use and/or physical |
| characteristics, this device is equivalent to devices | |
| currently marketed by U.S. companies. It is Substantially | |
| Equivlalent to the devices manufactured by Shield Gloves | |
| Manufacturer (M) K943807, and YTY Industry (Manjung) | |
| SDN BHD, K974191 (natural color). |
EXHIBIT N
Page 101 of 103
1
7.0 Summary of Performance Data:
Performance data of gloves based on ASTM D3578-01 and FDA 1000ML watertight test.
| TEST | ASTM D3578-01/AE2 | EVERGREEN POWDERED
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) | Min 18 | 23 - 27 |
| Ultimate Elongation (%) | Min 650 | 820 - 880 |
| Stress at 500% Elongation | Max 5.5 | 2.9-3.6 |
| After Aging
Tensile Strength (MPa) | Min 14 | 20 - 27 |
| Ultimate Elongation (%) | Min 500 | 780 - 860 |
| 6. Powder Content | 10mg per square decimeter max | Below 10 mg per square decimeter |
EXHIBIT N
Page 102 of 103
Page 2 of 3
2
510k) Summary page 2.
Test Results (Means and/or Successful Results:
This device has met or exceeded the following standards and/or tests:
ASTM D 5712-99 ASTM D 3578-01aE2 ASTM D 6124-01 ASTM D 5151-99 ISO 2859
Bio-Compatibility: Dermal Sensitization Primary Skin Irritation
Conclusion:
This device is substantially equivalent to the devices approved as K943807 and K974191.
EXHIBIT N
Page 103 of 103
3
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract image of a stylized caduceus, a symbol often associated with medicine and healthcare. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
8 2002 NOV
YTY Industry (Manjung) Sdn Bhd C/O Ms. Janna P. Tucker Tucker & Associates 198 Avenue De La D'emerald Sparks, Nevada 89434-9550
Re: K023590
Trade/Device Name: Powdered, Natural, Pink and Blue Colored Latex Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: October 23, 2002 Received: October 25, 2002
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 (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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 Dunn
Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE
APPLICANT: YTY INDUSTRY (MANJUNG) SDN. BHD.
510(k) NUMBER: KO23590
POWDERED, NATURAL AND/OR (Pink, Buce) DEVICE NAME: COLORED LATEX EXAM GLOVES
A 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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Qlin S. Lin
sion Sign-Off) on of Anesthesiology, General Hospital, on Control. Dental Device
EXHIBIT B
Page 2 of 103
510(k) Number: K 923080