(115 days)
Not Found
Not Found
No
The device description and performance studies focus on the physical properties and safety of a medical glove, with no mention of AI or ML technology.
No
The device is a medical glove used to prevent contamination, not to treat a disease, injury, or medical condition.
No
Explanation: The device, a medical glove, is intended to prevent contamination and is described as a Class I latex patient examination glove. Its function is to protect both healthcare personnel and patients, not to diagnose a condition.
No
The device description clearly states it is a "Class I latex patient examination glove," which is a physical hardware device.
No, 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 physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description clearly identifies it as a "medical glove" and references a standard for "Latex Examination Gloves for Medical Application."
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on the physical integrity (water tight test), biocompatibility (skin irritation/sensitization), and residual powder content of the glove itself, not on its ability to diagnose a condition.
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 definition.
N/A
Intended Use / Indications for Use
A medical glove to be worn on the hand of the health care and similar personnel to prevent contamination between health care personnel and patient.
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)
LZA
Device Description
Class I latex patient examination glove 80LZA, powder free and meeting all the requirements of ASTM-D3578-61) Standard Specification for Latex Examination Gloves for Medical Application, except for the elongation at break parameter.
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)
- Water Tight Test: Using the FDA specified 1,000 ml water leak test, 125 pieces of each size of the gloves were tested.
- UN-AGED: X-Small (2 leaked), Small (0 leaked), Medium (1 leaked), Large (0 leaked)
- AGED: X-Small (1 leaked), Small (2 leaked), Medium (1 leaked), Large (0 leaked)
- The figures are within the gloves of 2.5% AQL.
- Biocompatibility: The bio-compatibility test results show that the glove is neither a dermal irritant nor a skin sensitizer.
- Total Residual Powder Content & Presence of Cornstarch:
- Residual Powder Content (ASTM D 6124-00): Range: 0.7-1.5mg/glove, Mean: 1.05 mg/glove (FDA requirement: 2 mg/glove max)
- Presence of Cornstarch: Negative (FDA requirement: Negative)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Water leak test: AQL of 2.5%
- Residual Powder Content: Range: 0.7-1.5mg/glove, Mean: 1.05 mg/glove
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
SEP 1 7 2001
APPENDIX K
510(k) SUMMARY
SUMMARY OF THE SAFETY AND EFFECTIVENESS FOR POWIDER-FREE, "BARRIER-PROw", SYNTHETIC BUTADIENE CO-POLYMER EXAM GLOVES, COLOR: GREEN
KO11613
Contact person : Ong Lay Mau
This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
Device Information:
Trade Name - See above complete title for this exam glove.
Common Name - Exam gloves
Classification Name - Patient examination glove (per 21 CFR 880 6250)
Classification Information - Class I latex patient examination glove 80LZA powder free and meeting all the requirements of ASTM-D3578-01 Standard Specification for Latex Examination Gloves for Medical Application ( except for the elongation at break parameter.
Device Description:
Class I latex patient examination glove 80LZA, powder free and meeting all the requirements of ASTM-D3578-61) Standard Specification for Latex Examination Gloves for Medical Application, except for the elongation at break parameter.
Intended Use of Device:
A medical glove to be worn on the hand of the health care and similar personnel to prevent contamination between health care personnel and patient.
Technological Characteristics of Device.
1. Dimension
| DIMENSION | ASTM D3578-99 | Shield Gloves |
|---|---|---|
| X-Small | 70 mm +/- 10 mm | 70 - 75 mm |
| Small | 80 mm +/- 10mm | 80 - 85 mm |
| Medium | 95 mm +/- 10mm | 90 - 97 mm |
| Large | 111mm +/- 10mm | 105-111 mm |
| Length | 230 mm minimum | |
| for all sizes | 242mm | |
| Thickness - | ||
| Finger | ||
| Palm | 0.08mm min | |
| 0.08mm min | 0.08 mm min | |
| 0.08 mm min |
(Revised 8-9-01)
(Revised 9-10-01)
1
| TENSILE STRENGTH | ULTIMATE ELONGATION | |||
|---|---|---|---|---|
| ASTM-D3578-00 | SGMP | ASTM-D3578-00 | SGMP | |
| Mpa | Mpa | % | % | |
| Before Aging | 14.0 | 700 | ||
| X-Small | 25.3 | 840 | ||
| Small | 26.0 | 850 | ||
| Medium | 28.9 | 860 | ||
| Large | 22.0 | 840 | ||
| After Aging | 14.0 | 500 | ||
| X-Small | 21.3 | 890 | ||
| Small | 23.4 | 930 | ||
| Medium | 23.6 | 940 | ||
| Large | 21.7 | 900 |
-
- Physical Properties (ASTM-D3578-00 Standard Specification for Latex Exam Gloves) on Lot# 1128
3. Water Tight Test
Using the FDA specified 1,000 ml water leak test, 125 pieces of each size of the gloves were tested and our results are as given below:
| BATCH #
1128 | SIZE | SAMPLE SIZE | LEAK STATUS | NUMBER
LEAKED |
|-----------------|---------|-------------|-------------|------------------|
| UN-AGED | | | | |
| | X-Small | 125 | Yes | 2 |
| | Small | 125 | No | 0 |
| | Medium | 125 | Yes | 1 |
| | Large | 125 | No | 0 |
| AGED | | | | |
| | X-Small | 125 | Yes | 1 |
| | Small | 125 | Yes | 2 |
| | Medium | 125 | Yes | 1 |
| | Large | 125 | No | 0 |
The above figures are within the gloves of 2.5% AQL.
. FDA/ASTM D3578-00 requirements for latex exam
89
2
Biocompatibility ﻧ
The bio-compatibility test results show that the glove is neither a dermal irritant nor a skin sensitizer.
5. Total Residual Powder Content & Presence of Cornstarch
| TESTS
| REQUIREMENT | FDA | Shield's |
|---|---|---|
| Residual Powder | ||
| Content | ||
| (ASTM D 6124-00) | 2 mg/glove max | Range: 0.7-1.5mg/glove |
| Mean : 1.05 mg/glove | ||
| Presence of Cornstarch | Negative | Negative |
Conclusion :-
The data presented indicate that this Synthetic Butadiene Co-Polymer glove.
- meets/exceeds ASTM- D3578 Standard Specifications For Latex Examination Glove, except for 1. the elongation at break parameter,
- meets FDA pinhole requirements, ಗಳ
- meets FDA claim criterion of a powder free glove, ਡ
510(K) Summary Page 3 of 3
Revised 8-9-01)
Revised 9-10-01)
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 symbol resembling an eagle or bird with three curved lines representing its wings or body.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 7 2001
Shield Gloves Manufacturing (M) Sdn Bhd C/O Ms. Janna P. Tucker Official Correspondent Tucker & Associates 198 Avenue De La D' Emerald Sparks, Nevada 89434-9550
Re: K011613
Trade/Device Name: Powder-Free Green "Barrier-Pro™" Synthetic Butadiene Copolymer Examination Glove Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA Dated: July 9, 2001 Received: July 13, 2001
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 - Mr. Tucker
of the Act or any Federal statutes and regulations administered by other Federal agencies. of the Act of ally I ederal states and squirements, including, but not limited to: registration 1 ou must comply with and are rabeling (21 CFR Part 801); good manufacturing practice and ilsung (21 OF R Part 807), as ality systems (QS) regulation (21 CFR Part 820); and if requirences as betronic product radiation control provisions (section 531-542 of the Act; 21): CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your 510(k) I mis letter will and in the FDA finding of substantial equivalence of your device to a premaired 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 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 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,
Timothy A. Ulstanski
Timoth A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
5
INDICATIONS FOR USE STATEMENT
Applicant: Shield Gloves Manufacturer (M) Sdn. Bhd.
Koll613 510K Number:
Device Name: NON-STERILE, POWDER-FREE, "BARREER-PROTH" SYRTHETIC NON-STERILE, POWDER-FREE, "BARIOVES, COLOR: GREEN
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 ... Per 21 CFR 801.109 OR
Over-The-Counter ...
(Revised 9-10-01)
²
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Device 10(k) Number