(33 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 intended for preventing contamination between healthcare personnel and patients, and its description and performance studies focus on its barrier properties and safety for this purpose, not on treating or diagnosing a disease or condition.
No
Explanation: The device is a medical glove intended to prevent contamination, not to diagnose a disease or condition. Its described uses and performance studies focus on barrier properties and safety, not diagnostic capabilities.
No
The device is a physical medical glove made of latex, not software. The description focuses on material properties and performance tests related to a physical product.
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 patients by being worn on the hand. This is a barrier function, not a diagnostic function performed in vitro (outside the body).
- Device Description: The device is described as a Class I latex patient examination glove. This classification and description align with a physical barrier device, not an IVD.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (like blood, urine, tissue, etc.) or to provide information about a patient's health status or condition.
- Performance Studies: The performance studies focus on the physical properties of the glove (water tightness, biocompatibility, powder content, protein level), which are relevant to its barrier function and safety for contact, not its ability to diagnose.
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 those functions.
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)
LYY
Device Description
Class I latex patient examination gloves 80LYY, powder free and meeting all the requirements of ASTM-D3578-95 Standard Specification for Latex Examination Gloves for Medical Application.
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
1. Dimension
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2. Physical Properties
TENSILE STRENGTH:
Before Aging ASTM-D3578-95: 14.0 Mpa min, SHIELD's: 21.0 Mpa
After Aging 22 hrs @100C ASTM-D3578-95: 14.0 Mpa min, SHIELD's: 16.0 Mpa
ULTIMATE ELONGATION:
Before Aging ASTM-D3578-95: 700 %, SHIELD's: 800%
After Aging 22 hrs @100C ASTM-D3578-95: 500%, SHIELD's: 750%
3. Water Tight Test
Using the FDA specified 1,000 ml water leak test, 80 pieces of each size of the gloves were tested.
BATCH #: 9903031019, SIZE: X-Small, SAMPLE SIZE: 200, LEAK STATUS: Yes
BATCH #: 9903222024, SIZE: Small, SAMPLE SIZE: 200, LEAK STATUS: Yes, NUMBER LEAKED: 2
BATCH #: 9904011027, SIZE: Medium, SAMPLE SIZE: 200, LEAK STATUS: Yes
BATCH #: 9903162023, SIZE: Large, SAMPLE SIZE: 200, LEAK STATUS: Yes
The above figures are within the FDA/ ASTM requirements for latex exam gloves of 4.0% AQL.
4. Biocompatibility
Primary Dermal Irritation Test: Not a primary irritant
Skin Sensitization Study: Not a sensitiser
5. Total Residual Powder Content & Presence of Cornstarch
Residual Powder Content per ASTM D 6124-97:
FDA INTERNAL REQUIREMENT: 2 mg/glove max
SHIELD's: Range: 1.5-1.9mg/glove, Mean : 1.7 mg/glove
Presence of Cornstarch:
FDA INTERNAL REQUIREMENT: Negative
SHIELD's: Negative
6. Residual Protein Level
ASTM D 5712-95:
FDA ALLOWABLE LEVEL:
§ 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.
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APPENDIX H
510(k) SUMMARY SUMMARY OF THE SAFETY AND EFFECTIVENESS FOR ROYAL SHIELD POWDER FREE GREEN LATEX EXAMINATION GLOVES WITH A PROTEIN CONTENT LABELING
Contact person : Ong Lay Mau
Gloves for Medical Application.
This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
Device Information:
Trade Name - ROYAL SHIELD POWDER FREE GREEN LATEX EXAM GLOVES Common Name - Exam gloves Classification Name - Patient examination glove (per 21 CFR 880.6250) Classification Information - Class I latex patient examination glove 80L YY, powder free and meeting all the requirements of ASTM-D3578-95 Standard Specification for Latex Examination
Device Description:
Class I latex patient examination gloves 80LYY, powder free and meeting all the requirements of ASTM-D3578-95 Standard Specification for Latex Examination Gloves for Medical Application.
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 D3578-95 | ROYAL SHIELD |
|---|---|---|
| X-Small | ||
| Small | ||
| Medium | ||
| Large | 70 mm +/- 10 mm | |
| 80 mm +/- 10mm | ||
| 95 mm +/- 10mm | ||
| 111mm +/- 10mm | 70 - 75 mm | |
| 80 - 85 mm | ||
| 90 - 97 mm | ||
| 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 |
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K9911745
| TENSILE STRENGTH | ULTIMATE ELONGATION | |||
|---|---|---|---|---|
| ASTM-D3578-95 | SHIELD's | ASTM-D3578-95 | SHIELD's | |
| Before Aging | 14.0 Mpa min | 21.0 Mpa | 700 % | 800% |
| After Aging | ||||
| 22 hrs @100C | 14.0 Mpa min | 16.0 Mpa | 500% | 750% |
- Physical Properties (ASTM-D3578-95 Standard Specification for Latex Exam Gloves)
3. Water Tight Test
Using the FDA specified 1,000 ml water leak test, 80 pieces of each size of the gloves were tested and our results are as given below:
| BATCH # | SIZE | SAMPLE SIZE | LEAK STATUS | NUMBER
LEAKED |
|------------|---------|-------------|-------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 9903031019 | X-Small | 200 | Yes | |
| 9903222024 | Small | 200 | Yes | 2 |
| 9904011027 | Medium | 200 | Yes | |
| 9903162023 | Large | 200 | Yes | ﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ |
The above figures are within the FDA/ ASTM requirements for latex exam gloves of 4.0% AQL.
4. Biocompatibility
The test results below show that the gloves meet FDA biocompatibility requirements:
BIOCOMPATIBILITY TESTS
Primary Dermal Irritation Test
RESULTS
Not a primary irritant
Skin Sensitization Study
Not a sensitiser
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991745
| TESTS | FDA INTERNAL
REQUIREMENT | SHIELD's |
|--------------------------------------------------|-----------------------------|-----------------------------------------------|
| Residual Powder
Content per
ASTM D 6124-97 | 2 mg/glove max | Range: 1.5-1.9mg/glove
Mean : 1.7 mg/glove |
| Presence of Cornstarch | Negative | Negative |
5. Total Residual Powder Content & Presence of Cornstarch
6. Residual Protein Level
| TESTS | FDA ALLOWABLE LEVEL | CLAIMED LEVEL |
|---|---|---|
| ASTM D 5712-95 | Royal Shield™ Non-Sterile Powder-Free, Trade Name: Green Latex Examination Glove with Protein Content Labeling Claim (50 micrograms or less) Regulatory Class: I Product Code: LYY Dated: May 10, 1999 May 21, 1999 Received: |
Dear Mr. Smith:
We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Smith
this response to your premarket notification Please note: submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE STATEMENT
Applicant: Shield Gloves Manufacturer (M) Sdn Bhd.
510K Number:
Green Device Name: Royal Shield Powder Free Latex Examination Gloves With Content labeling Claim (50 micrograms or less 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.........X
Chiu S. Lim
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital D 510(k) Number _