(35 days)
Not Found
No
The summary describes a standard medical glove and its physical properties and performance against established standards. There is no mention of AI or ML capabilities.
No.
The intended use of the device is to prevent contamination between healthcare personnel and the patient, which is a barrier function, not a therapeutic treatment.
No
The device is a medical glove, a barrier intended to prevent contamination, not to diagnose a condition.
No
The device is a physical medical glove, not a software-only device. The description focuses on material properties, physical dimensions, and performance tests related to a tangible product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to be worn on the hand to prevent contamination between healthcare personnel and the patient. This is a barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: It is described as a "Latex Patient Examination Glove." This is a physical barrier device.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on the physical properties and barrier integrity of the glove (watertightness, dimensions, strength, powder content), which are relevant to its function as a protective barrier, not a diagnostic tool.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This glove does not perform any of these functions.
N/A
Intended Use / Indications for Use
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.
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 (comma separated list FDA assigned to the subject device)
LYY
Device Description
Class I Latex Patient Examination Glove 80 LYY, powdered with absorbable dusting powder, that meets all of the requirement 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
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 D3578-01 and FDA 1000ML watertight test.
TEST: Watertight (1000ml), ASTM D3578-01: Multiple Normal GI AQL = 2.5, POWDERED LATEX EXAM. GLOVES: Pass GI AQL = 2.5
TEST: Length (mm), Size XS/S/M/L/XL, ASTM D3578-01: Min 220/Min 220/Min 230/Min 230/-, POWDERED LATEX EXAM. GLOVES: 240 mm minimum for all sizes
TEST: Palm width (mm), Size XS/S/M/L/XL, ASTM D3578-01: 70 ± 10/80 ± 10/95 ± 10/111 ± 10/-, POWDERED LATEX EXAM. GLOVES: 73 - 78/83 - 88/93 - 98/103 - 107
TEST: Thickness (mm) (Single Layer) Finger/Palm, ASTM D3578-01: Min 0.08/Min 0.08, POWDERED LATEX EXAM. GLOVES: Min 0.10/Min 0.10
TEST: Physical Properties Before Aging Tensile Strength (MPa)/Ultimate Elongation (%)/Stress at 500% Elongation After Aging Tensile Strength (MPa)/Ultimate Elongation (%), ASTM D3578-01: Min 18/Min 650/Max 5.5/Min 14/Min 500, POWDERED LATEX EXAM. GLOVES: 26 - 30/820 - 940/2.0-3.3/24 - 30/840 - 920
TEST: Powder Content, ASTM D3578-01: 10mg per square decimetre max, POWDERED LATEX EXAM. GLOVES: Below 10 mg per square decimetre
This device has met or exceeded the following standards and/or tests: ASTM D 5712-99, ASTM D 3578-01aE2, ASTM D 5151-99, ASTM D 6124-01, 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
YTY INDUSTRY (MANJUNG) SDN. BHD.
Company No : 380830-P)
mpany No : 000304 7
1422-1424, Batu 10 Lekir, 32020 Sitiawan, Perak Darul Ridzuan, Malaysi�EB 0 3 2003 Tel : 05-6792288 (Hunting Line), 6792443 & 6792445 Fax : 05-6791188
APPENDIX I.
| 1.0 | 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 | 1. JANNA TUCKER | |
| Date of Summary Prepared | November 30, 2002 |
3.0 Name of Device
| Trade Name | Non-Sterile Powdered Natural or Colored Latex Examination Gloves (Multiple Private Labels) |
|---|---|
| Common Name | Exam Glove |
| Classification Name | Patient Examination Glove |
4.0 Identification of The Legally Marketed Devices
Class I Latex Patient Examination Glove 80 LYY, powdered with absorbable dusting powder, that meets all of the requirements of ASTM Standard D3578-01.
Description of The Device 5.0
Class I Latex Patient Examination Glove 80 LYY, powdered with absorbable dusting powder, that meets all of the requirement 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.
Page 1 of 3
1
7.0 Summary of Performance Data:
| TEST | ASTM D3578-01 | 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)
Ultimate Elongation (%)
Stress at 500% Elongation
After Aging
Tensile Strength (MPa)
Ultimate Elongation (%) | Min 18
Min 650
Max 5.5
Min 14
Min 500 | 26 - 30
820 - 940
2.0-3.3
24 - 30
840 - 920 |
| 6. Powder Content | 10mg per square decimetre max | Below 10 mg per square decimetre |
Performance data of gloves based on ASTM D3578-01 and FDA 1000ML watertight test.
2
510k) Summary page 3.
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 5151-99 ASTM D 6124-01 ISO 2859
Bio-Compatibility: Dermal Sensitization Primary Skin Irritation
Conclusion:
This device is substantially equivalent to the devices approved as K943807, K974191 and K023590.
3
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 0 3 2003
YTY Industry (Manjung) Sdn. Bhd. C/O Ms. Janna P. Tucker Official Correspondent Tucker & Associates 198 Avenue De La D'emerald Sparkes, Nevada 89434-9550
Re: K024355
Trade/Device Name: Non-Sterile, Powdered, Natural or Colored Latex Examination Gloves, Violet & Green Color Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: December 23, 2002 Received: December 30, 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 vour 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) 594-4618. 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 vours.
Susan Kunn
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 STATEMENT
.
:
Applicant: YTY INDUSTRY (MANJUNG) SDN BHD
Kost 35.5 510K NUMBER:
Non-Sterile, Powdered, Natural or Colored Latex Examination Gloves Device Name: (Violet & Green Color) (Multiple Private Label)
Indication 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 .................. Per 21 CFR 801.109
() () (
Over-The-Counter ... ... ... .................
・
Qhin S. Lin
nesthesiology. General H
510(k) Number: K 024355