(66 days)
Not Found
Not Found
No
The device description and performance studies focus on the physical properties and barrier function of a medical glove, with no mention of AI or ML.
No
The device is a medical glove intended for contamination prevention, not for treating or alleviating a disease or condition.
No
The device is a medical glove, described as preventing contamination between health care personnel and patients. Its performance evaluation focuses on physical properties and biocompatibility, not on detecting, diagnosing, or monitoring diseases or conditions.
No
The device description clearly states it is a medical glove, which is a physical hardware device, and the performance studies focus on physical properties and tests like watertightness and tensile strength. There is no mention of software components or functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to prevent contamination between healthcare personnel and the patient by being worn on the hand. This is a barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: It's described as a "Class 1 Patient Examination Glove." Examination gloves are physical barriers, not diagnostic devices.
- 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 health condition.
- Performance Data: The performance data focuses on physical properties like watertightness, dimensions, thickness, tensile strength, and biocompatibility – all relevant to a physical barrier device, not a diagnostic test.
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 fit that description.
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
LZA
Device Description
Class 1 Patient Examination Glove 80 LZA, powder free that meets all the requirements of ASTM Standard D6319-00a 3 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 D6319-00a2 and FDA 1000ML watertight test.
TEST: Watertight (1000ml), ASTM D6319-00a3: Multiple Normal GI AQL = 2.5, POWDER FREE NITRILE EXAM. GLOVES: Pass GI, AQL = 2.5
TEST: Length (mm) Size XS, ASTM D6319-00a3: Min 220, POWDER FREE NITRILE EXAM. GLOVES: 240 mm minimum for all sizes
TEST: Length (mm) Size S, ASTM D6319-00a3: Min 220, POWDER FREE NITRILE EXAM. GLOVES: 240 mm minimum for all sizes
TEST: Length (mm) Size M, ASTM D6319-00a3: Min 230, POWDER FREE NITRILE EXAM. GLOVES: 240 mm minimum for all sizes
TEST: Length (mm) Size L, ASTM D6319-00a3: Min 230, POWDER FREE NITRILE EXAM. GLOVES: 240 mm minimum for all sizes
TEST: Length (mm) Size XL, ASTM D6319-00a3: -, POWDER FREE NITRILE EXAM. GLOVES: 240 mm minimum for all sizes
TEST: Palm width (mm) Size XS, ASTM D6319-00a3: 70 ± 10, POWDER FREE NITRILE EXAM. GLOVES: 73-78
TEST: Palm width (mm) Size S, ASTM D6319-00a3: 80 ± 10, POWDER FREE NITRILE EXAM. GLOVES: 83 - 88
TEST: Palm width (mm) Size M, ASTM D6319-00a3: 95 ± 10, POWDER FREE NITRILE EXAM. GLOVES: 93 - 98
TEST: Palm width (mm) Size L, ASTM D6319-00a3: 111 ± 10, POWDER FREE NITRILE EXAM. GLOVES: 103 - 107
TEST: Palm width (mm) Size XL, ASTM D6319-00a3: -, POWDER FREE NITRILE EXAM. GLOVES: -
TEST: Thickness (mm) (Single Layer) Finger, ASTM D6319-00a3: Min 0.05, POWDER FREE NITRILE EXAM. GLOVES: Min 0.08
TEST: Thickness (mm) (Single Layer) Palm, ASTM D6319-00a3: Min 0.05, POWDER FREE NITRILE EXAM. GLOVES: Min 0.08
TEST: Physical Properties Before Aging Tensile Strength (MPa), ASTM D6319-00a3: Min 14, POWDER FREE NITRILE EXAM. GLOVES: 23-26
TEST: Physical Properties Before Aging Ultimate Elongation (%), ASTM D6319-00a3: Min 500, POWDER FREE NITRILE EXAM. GLOVES: 700 - 840
TEST: Physical Properties After Aging Tensile Strength (MPa), ASTM D6319-00a3: Min 14, POWDER FREE NITRILE EXAM. GLOVES: 18-24
TEST: Physical Properties After Aging Ultimate Elongation (%), ASTM D6319-00a3: Min 400, POWDER FREE NITRILE EXAM. GLOVES: 660 - 760
TEST: Powder Content, ASTM D6319-00a3: Max 2.0mg/glove, POWDER FREE NITRILE EXAM. GLOVES: Below 2 mg/glove
The performance data of the glove as shown above meet the ASTM D6319-00a" 8.0 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.
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
KO31580
GREEN PROSPECT SDN. BHD. (667515-0)
| JUL 2 5 2003 | APPENDIX-J | |
|---|---|---|
| 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 | April 23, 2003 | |
| 3.0 | Name of Device | |
| Trade Name: | Non-Sterile Powder Free, Blue Color Nitrile Examination Gloves | |
| Common Name: | Exam Glove | |
| Classification Name: | Patient Examination Glove | |
| 4.0 | Identification of The Legally Marketed Devices | |
| Class 1 Patient Examination Glove 80 LZA, powder free that meets all the requirements of | ||
| ASTM Standard D6319-00a 3 and FDA requirements. | ||
| 5.0 | Description of The Device | |
| Class 1 Patient Examination Glove 80 LZA, powder free that meets all the requirements of | ||
| ASTM Standard D6319-00a 3 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
Image /page/1/Picture/0 description: The image shows a sequence of handwritten alphanumeric characters. The characters are 'K031580'. The characters are written in black ink on a white background.
:
... . . . . . . . .
7.0 Summary of Performance Data:
Performance data of gloves based on ASTM D6319-00a2 and FDA 1000ML watertight test.
| TEST | ASTM D6319-00a3 | 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 0.08
Min 0.08 | |
| 5. Physical Properties
Before Aging
Tensile Strength (MPa)
Ultimate Elongation (%)
After Aging
Tensile Strength (MPa)
Ultimate Elongation (%) | Min 14
Min 500
Min 14
Min 400 | 23-26
700 - 840
18-24
660 - 760 | |
| 6. Powder Content | Max 2.0mg/glove | Below 2 mg/glove | |
2
Image /page/2/Picture/0 description: The image contains a handwritten alphanumeric string. The string appears to be "K031580". The characters are written in a cursive style, with some variability in stroke thickness.
- The performance data of the glove as shown above meet the ASTM D6319-00a" 8.0 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 Powder Free, Blue Color Nitrile Examination Gloves, meets:
- ASTM D6319-00a63Standard ・
- FDA pinhole requirements -
- Are below the maximum Powder Residual Content as specified in ASTM -D6319-00a63
3
Image /page/3/Picture/1 description: The image shows a black and white seal for the Department of Health & Human Services - USA. The seal is circular with text around the perimeter. Inside the circle is an emblem of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 5 2003
Green Prospect Sdn Bhd C/O Ms. Janna P. Tucker Tucker & Associates 198 Avenue De La D'emerald Sparks, Nevada 89434-9550
Re: K031580
Trade/Device Name: Non-Sterile, Powder-Free, Blue Color Nitrile Examination Glove Regulation Number: 21 CFR 880. 6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: June 24, 2003 Received: June 27, 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) 594-4618. 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,
SeAWitelson
fer
Susan Runner, DDDS, 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:
031580 510K Number:
Device Name: Non-Sterile, Powder-Free, Blue Color Nitrile Examination Glove
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.
Cffluthar
on of Anesthesiology, General Hospital, Infection Control, Dental De
510(k) Number: K031580
Concurrence of CDRH Office of Device Evaluation (ODE)
Prescription Use .......................... Per 21 CFR 801.109
OR
Over-The-Counter ...................