(65 days)
Not Found
Not Found
No
The summary describes a standard medical glove and does not mention any AI or ML capabilities.
No.
This device is a medical glove intended to prevent contamination, not to provide therapy or treatment.
No
This device is a medical glove designed to prevent contamination, not to diagnose a medical condition. Its function is protective, not diagnostic.
No
The device description clearly states it is a physical medical glove made of latex, and the performance studies focus on physical properties and watertightness, not software functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as 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." This describes a physical barrier device used for infection control, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a "Class 1 Latex Patient Examination Glove," which is 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 or measuring substances in samples
- Providing diagnostic information
- Using reagents or assays
The information provided focuses on the physical properties and performance of the glove as a barrier, which is consistent with a Class I medical device for infection control.
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
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
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.
Key Results:
- Watertight (1000ml): Pass GI, AQL = 2.5
- Length: 240 mm minimum for all sizes
- Palm width: XS (73-78), S (83-88), M (93-98), L (103-107)
- Thickness (Single Layer): Finger (Min 0.10), Palm (Min 0.10)
- Physical Properties (Before Aging): Tensile Strength (22-24 MPa), Ultimate Elongation (820-900%), Stress at 500% Elongation (2.2-2.9)
- Physical Properties (After Aging): Tensile Strength (22-24 MPa), Ultimate Elongation (800-860%)
- Powder Content: Below 2 mg/glove
- Protein Content: Below 50 microgram/gram
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.)
See Summary of Performance Studies.
Predicate Device(s)
Not Found
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
K03158/
| GREEN PROSPECT SDN. BHD. (567515-D) |
|---|
| ------------------------------------- |
| JUL 24 2003 |
|---|
| ------------- |
APPENDIX-K
| 1.0 | SMDA 510 (K) SUMMARY | |
|---|---|---|
| 2.0 | Submitter | Green Prospect Sdn Bhd |
| Lot 14803, Kawasan Perindustrian | ||
| Kg. Acheh, Sitiawan, Lumut | ||
| Perak Darul Ridzuan | ||
| MALAYSIA | ||
| Tel | 605-6911288 | |
| Fax | 605-6922388 | |
| Name of Contact Person | 1. MS. WONG YOKE CHENG | |
| Date of Summary Prepared | March 20, 2003 | |
| 3.0 | Name of Device | |
| Trade Name | Non-Sterile Powder Free, Latex Examination Gloves, Polymer Coated | |
| White Color, with Protein Labeling, Contains 50 Micrograms or Less of | ||
| Total Water Extractable Protein Per Gram | ||
| (Multiple Private Labels): | ||
| 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. | ||
| Page 1 of 3 |
Lot 14803, Kawasan Perindustrian, Kampung Acheh, 32000 Sitiawan, Perak Darul Ridzuan, Malaysia.
1
Summary of Performance Data: 7.0
ﺮ
r
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 | $70 \pm 10$
$80 \pm 10$
$95 \pm 10$
$111 \pm 10$
- | 73 - 78
83 - 88
93 - 98
103 - 107
. | |
| 4. Thickness (mm)
(Single Layer)
Finger
Palm | Min 0.08
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 | Min 18
Min 650
Max 5.5 | 22 - 24
820 - 900
2.2-2.9 | |
| Tensile Strength (MPa)
Ultimate Elongation (%) | Min 14
Min 500 | 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
●
The performance data of the glove as shown above meet the ASTM D3578-01 8.0 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.
- 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.
- Conclusion 10.0
We concluded that the Multiple Private Labeled Non-Sterile Powder Free, Latex Examination Gloves, Polymer Coated Natural and/or Colored with Protein Labeling, Contains 50 Micrograms or Less of Total Water Extractable Protein 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 ﺖ Extractable Protein.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol that resembles an eagle or a bird in flight, composed of three curved lines. The emblem is positioned in the upper right portion of the circle.
Public Health Service
JUL 2 4 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Green Prospect Sdn Bhd C/O Ms. Janna P. Tucker Tucker & Associates 198 Avenue De La D'emerald Sparks, Nevada 89434-9550
Re: K031581
Trade/Device Name: Non-Sterile Powder Free, Latex Examination Gloves, Polymer Coated White Color with Protein Labeling, Contains 50 Micrograms or Less of Total Water Extractable Protein Per Gram Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: July 3, 2003 Received: July 7, 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 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 - Mr. 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 (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 yours,
fAWit-h
for
san 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
Green Prospect Sdn Bhd Applicant:
KO31581 510K Number:
Device Name: Non-Sterile Powder Free, Latex Examination Gloves, Polymer Coated White Color, with Protein Labeling, Contains 50 Micrograms or Less of Total Water Extractable Protein 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)
costh
ion of Anesthesiology. G Infection Control. Den
510(k) Number: K031581
Prescription Use .................................... Per 21 CFR 801.109
OR
Over-The-Counter .................