(98 days)
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.
Class I Nitrile patient examination gloves 80LZA, powder free and meeting all the requirements of the ASTM Draft Standard Specification for Nitrile Examination Gloves for Medical Application.
Here's a breakdown of the acceptance criteria and study information for the ROYAL SHIELD™ POWDER FREE COLORED NITRILE EXAMINATION GLOVES, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Property | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dimension | ||
| X-Small (Width) | 70 mm +/- 10 mm | 70 - 75 mm |
| Small (Width) | 80 mm +/- 10 mm | 80 - 85 mm |
| Medium (Width) | 90 mm +/- 10 mm | 90 - 97 mm |
| Large (Width) | 100 mm +/- 10 mm | 105 - 100 mm |
| Length (All Sizes) | 230 mm minimum | 240 mm minimum |
| Thickness - Finger | 0.08 mm minimum | 0.08 mm minimum |
| Thickness - Palm | 0.08 mm minimum | 0.08 mm minimum |
| Physical Properties | ||
| Tensile Strength (Before Aging) | 14.0 MPa (ASTM D3578-95); 12.5 MPa (ASTM Draft Nitrile) | 15.6 MPa |
| Tensile Strength (After Aging) | 14.0 MPa (ASTM D3578-95); 12.5 MPa (ASTM Draft Nitrile) | 14.5 MPa |
| Ultimate Elongation (Before Aging) | 700% (ASTM D3578-95); 500% (ASTM Draft Nitrile) | 650% (Meets ASTM Draft Nitrile, does not meet ASTM D3578-95) |
| Ultimate Elongation (After Aging) | 500% (ASTM D3578-95); 400% (ASTM Draft Nitrile) | 575% |
| Water Tight Test | Meets FDA Water Leak Test Requirements (implied: very low leakage rate, typically <2.5% for AQL 1.5) | Small: 0/80 leaked; Medium: 1/80 leaked; Large: 1/80 leaked (Meets FDA requirements) |
| Biocompatibility | Meets FDA biocompatibility requirements (implied: passes irritation and sensitization tests) | Primary Dermal Irritation Test: Passes; Skin Sensitization Study: Passes |
| Residual Powder Content | Not exceeding 2 mg per glove (FDA Internal Requirement / ASTM Draft Method) | Range: 1.6-2.0 mg/glove; Mean: 1.8 mg per glove |
| Cornstarch Presence | Negative (Iodine Test) | Negative |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Water Tight Test): 80 pieces per batch (total of 240 pieces across Small, Medium, and Large sizes for batch 9705261002).
- Sample Size (Other Tests): Not explicitly stated for each test, but it is implied that samples from the production of "ROYAL SHIELD" gloves were used for all listed tests.
- Data Provenance: The manufacturing company is Shield Gloves Manufacturer (M) Sdn. Bhd. located in Malaysia. The data is thus likely derived from their testing processes, which would be retrospective in nature for this submission, as they are reporting on already manufactured and tested products.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- None stated. The "ground truth" for the performance tests relies on established ASTM standards and FDA internal requirements for medical device testing, not expert consensus on specific cases. For example, a "Pass" on a Dermal Irritation Test is based on standardized experimental protocols, not an expert's subjective judgment.
4. Adjudication Method for the Test Set
- None stated. Due to the nature of the device (examination gloves) and the type of performance testing (physical properties, leak tests, biocompatibility), adjudication by multiple experts is not applicable. The results are quantitative measurements or pass/fail outcomes based on standardized protocols.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This type of study (MRMC) is relevant for diagnostic or interpretive devices where human readers evaluate cases, often with and without AI assistance, to assess the AI's impact on reader performance. This device is an examination glove, which does not involve human interpretation of cases or images.
6. Standalone Performance Study
- Yes, implicitly. All the reported tests (dimension, physical properties, water leak, biocompatibility, powder content) reflect the standalone performance of the glove itself, without any human-in-the-loop interaction beyond handling for the test procedure. The data directly quantifies the device's characteristics against predefined standards.
7. Type of Ground Truth Used
- The "ground truth" used for evaluating the device's performance is based on established industry standards and regulatory requirements:
- ASTM D3578-95 (Standard Specification for Rubber Examination Gloves)
- ASTM Draft Standard Specification for Nitrile Examination Gloves for Medical Application
- FDA specified 1,000 ml water leak test requirements
- FDA biocompatibility requirements
- FDA Internal Requirement for residual powder content
- ASTM D 5151-90 Test Method for Detection of Holes in Medical Gloves (mentioned in conclusion)
8. Sample Size for the Training Set
- Not applicable. This device is a physical product (medical glove) and not an AI/machine learning algorithm that requires a "training set" of data. The manufacturing process is controlled to produce gloves that meet specifications.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As a physical product, there is no "training set" or corresponding ground truth establishment in the context of machine learning. The "ground truth" for manufacturing quality control would be the adherence to the ASTM standards and FDA requirements listed in point 7.
{0}------------------------------------------------
972757
APPENDIX J
OCT 29 1997
510(K) SUMMARY SUMMARY OF THE SAFETY AND EFFECTIVENESS FOR ROYAL SHIELD POWDER FREE NITRILE EXAMINATION GLOVES
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 | - ROYAL SHIELD™ POWDER FREE COLORED NITRILEEXAMINATION GLOVES |
|---|---|
| Common Name | - Exam gloves |
| Classification Name | - Patient examination glove (per 21 CFR 880.6250) |
| Classification Information | - Class I, 80 LZA - Nitrile patient examination glove, Powder free |
| Meets all requirements of the ASTM Draft Standard Specification | |
| for Nitrile Examination Gloves for Medical Application. |
Device Description:
Class I Nitrile patient examination gloves 80LZA, powder free and meeting all the requirements of the ASTM Draft Standard Specification for Nitrile 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-SmallSmallMediumLarge | 70 mm +/-10 mm80 mm +/- 10mm90 mm +/- 10mm100mm +/- 10mm | 70 - 75 mm80 - 85 mm90 - 97 mm105 - 100 mm |
| Length | 230 mm minimumfor all sizes | 240mm min.for all sizes |
| Thickness -FingerPalm | 0.08mm minimum0.08mm minimum | 0.08 mm min.0.08 mm min. |
{1}------------------------------------------------
Physical Properties 2.
| TESTS | TENSILE STRENGTH | ULTIMATE ELONGATION | ||||
|---|---|---|---|---|---|---|
| ASTMD 3578-95 | ASTMDRAFTNITRILE | SHIELDGLOVESMFR'S | ASTMD 3578-95 | ASTMDRAFTNITRILE | SHIELDGLOVESMFR'S | |
| BEFORE AGING | 14.0 MPa | 12.5 MPa | 15.6 MPa | 700% | 500% | 650% |
| AFTER AGING22 HRS @ 100°C | 14.0 MPa | 12.5 MPa | 14.5 MPa | 500% | 400% | 575% |
Our Royal Shield™ Powder free, Colored Nitrile gloves meets all the current ASTM D 3578-95 standards except for Ultimate Elongation Percentages Before Aging.
However, these gloves meet all the specifications of the ASTM Draft Specification for "Nitrile Rubber Examination Gloves for Medical Application" (see APPENDIX B-1) and will conform to all the requirements of the final ASTM standard for Nitrile gloves when published.
3. Water Tight Test
Using the FDA specified 1,000 ml water leak test, 80 pieces of the gloves were tested and our results are as given below: 【送料無料】【送料無料】【送料無料】【送料無料】【送料無料】【送料無料】【送料無料】【送料無料】【送料無料】【送料無料】【送料無料】【送料無料】【
| BATCH # | SIZE | SAMPLE SIZE | LEAK STATUS | NUMBERLEAKED |
|---|---|---|---|---|
| 9705261002 | Small | 80 | No | 0 |
| 9705261002 | Medium | 80 | Yes | 1 |
| 9705261002 | Large | 80 | Yes | 1 |
The above meets the FDA Water Leak Test Requirements.
4. Biocompatibility
The test results below shows that the gloves meet FDA biocompatibility requirements:
| BIOCOMPATIBILITY TESTS | RESULTS |
|---|---|
| Primary Dermal Irritation Test | Passes |
| Skin Sensitization Study | Passes |
{2}------------------------------------------------
| TESTS | FDA INTERNALREQUIREMENTS | SHIELD GLOVES MFR'S |
|---|---|---|
| RESIDUAL POWDERCONTENT(ASTM DRAFT METHOD) | NOT EXCEEDING2 MG PER GLOVE | RANGE: 1.6-2.0 MG/ GLOVEMEAN : 1.8 MG PER GLOVE |
| CORNSTARCH PRESENCE(IODINE TEST) | NEGATIVE | NEGATIVE |
5. Total Residual Powder Content & Presence of Cornstarch
Our above glove conforms to FDA's Internal Requirement not to exceed 2 mg/glove of total powder residue (using ASTM Draft Method for Residual Powder on Medical Gloves) and negative Iodine test.
CONCLUSION :-
It is concluded that the Royal Shield TM Powder Free, Colored Nitrile gloves meet .-
- ASTM D 3578-95 with the exception of Ultimate Elongation Percentages Before Aging (700% standard Vs. 650% for our product).
- ASTM Draft Standard Specification for Nitrile Examination Gloves for Medical Application and will conform to this final standard when published.
- FDA Internal Requirement not to exceed 2 mg/glove of total powder residue (using ASTM Draft Method for Residual Powder on Medical Gloves.
- ASTM D 5151-90 Test Method for Detection of Holes in Medical Gloves
- the FDA Water Leak Test requirements
{3}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES ----------------------------------------------------------------------------------------------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three stylized wing or feather shapes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
OCT 2 9 1997
Mr. Onq Lay Mau Executive Director Shield Gloves Manufacturer (M) Sdn. Bhd. 87, 2nd. Floor, Jalan SS 15/4-C Subang Jaya Petaling Jaya, Selangor Darul Ehsan Malaysia
Re : K972757 ROYAL SHIELD™ Non-Sterile Powderfree, Trade Name: Colored Nitrile Examination Glove (Blue) Regulatory Class: I Product Code: LZA Dated: October 11, 1997 Received: October 20, 1997
Dear Mr. Mau:
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, Drug, 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 reqistration, 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. ਉ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements
{4}------------------------------------------------
Page 2 - Mr. Mau
concerning your device in the Federal Register. Please note: this response to your premarket notification 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 leqally 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 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" (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,
Alilatoun
thy A. Ulatowski Timo Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
{5}------------------------------------------------
INDICATIONS FOR USE STATEMENT
Applicant: Shield Gloves Manufacturer (M) Sdn Bhd
510K Number: |<972757
Device Name: ROYAL SHIELD ™ Powder Free Colored Nitrile Examination Gloves / BULC
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)
・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・
Clim S. Lin
(Division Sign-Off Division of Dental. and General Ha 510(k) Numbe
Prescription Use ...... Per 21 CFR 801.109
Over-The-Counter........X......
OR
§ 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.