(55 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 latex patient examination gloves 80LYY, powdered and meeting all the requirements of ASTM-D3578-99 Standard Specification for Latex Examination Gloves for Medical Application.
The provided text describes the acceptance criteria and performance data for ROYAL SHIELD BLUE COLORED POWDERED LATEX EXAMINATION GLOVES. This document does not pertain to an AI-powered device or software for medical imaging analysis. Therefore, many of the requested points, such as those related to AI effectiveness, ground truth establishment for AI, expert qualifications, and training/test sets for algorithms, are not applicable.
Here's the information that can be extracted based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (from ASTM-D3578-99 unless otherwise noted) | Reported Device Performance (Shield Gloves) |
|---|---|---|
| Dimensions | ||
| Width (Ambidextrous) | X-Small: 70 mm +/- 10 mmSmall: 80 mm +/- 10 mmMedium: 95 mm +/- 10 mmLarge: 111 mm +/- 10 mm | |
| Width (Size Fitted) | 5.5: 70 +/- 10 mm6.0: 76 +/- 10 mm6.5: 83 +/- 10 mm7.0: 89 +/- 10 mm7.5: 95 +/- 10 mm8.0: 102 +/- 10 mm8.5: 108 +/- 10 mm9.0: 114 +/- 10 mm | |
| Length | 230 mm min | 230 mm (implied to meet or exceed) |
| Thickness - Finger | 0.08 mm min | 0.08 mm min |
| Thickness - Palm | 0.08 mm min | 0.08 mm min |
| Physical Properties | ||
| Tensile Strength (Aged) | 14.0 MPa min | Shield: 27.7 MPa, 25.2 MPa, 29.1 MPa (all meet/exceed) |
| Tensile Strength (Unaged) | 14.0 MPa min | Shield: 24.3 MPa, 30.3 MPa, 30.1 MPa (all meet/exceed) |
| Ultimate Elongation (Aged) | 500% min | Shield: 950%, 900%, 950% (all meet/exceed) |
| Ultimate Elongation (Unaged) | 700% min | Shield: 900%, 900%, 900% (all meet/exceed) |
| Watertightness | 2.5% AQL (Acceptable Quality Level) | Batch 9028-9035 S: 4 leaks out of 315 samples (1.27%)Batch 9030-9036 M: 7 leaks out of 315 samples (2.22%)Batch 9027-9031 L: 3 leaks out of 200 samples (1.5%)(All within 2.5% AQL requirement) |
| Biocompatibility | Not a primary irritantNot a sensitizer | Primary Dermal Irritation Test: Not a primary irritantSkin Sensitization Study: Not a sensitiser |
| Residual Protein Level | < 200 µg/g (per FDA allowable level / labeling claim) | < 200 µg/g (Claimed Level based on ASTM D 5712-95) |
2. Sample Sizes Used for Test Set and Data Provenance
- Physical Properties (Tensile Strength & Ultimate Elongation): The table shows 3 data points for each measurement, implying at least 3 samples were tested.
- Watertightness:
- Batch 9028-9035 S: 315 samples
- Batch 9030-9036 M: 315 samples
- Batch 9027-9031 L: 200 samples
- Data Provenance: The country of origin for the data is not specified, but the manufacturer is "Shield Gloves Manufacturer (M) Sdn. Bhd.", suggesting an origin outside the US (Sdn. Bhd. is a Malaysian company type). The data appears to be prospective testing performed on the manufactured gloves to demonstrate compliance before market release.
3. Number of Experts and Qualifications for Ground Truth
- Not applicable. This document describes physical and chemical testing of a medical device (gloves), not an AI system requiring expert interpretation for ground truth.
4. Adjudication Method for the Test Set
- Not applicable. The tests performed are objective measurements following standard ASTM methods or biological tests, not subjective interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not applicable. This relates to human reader performance with and without AI, which is irrelevant for a latex glove.
6. Standalone (Algorithm Only) Performance Study
- Not applicable. This relates to the performance of an AI algorithm on its own, which is irrelevant for a latex glove.
7. Type of Ground Truth Used
- Objective Measurements and Standardized Tests: The "ground truth" for the glove's performance is established through:
- Direct physical measurements (dimensions, thickness).
- Mechanical stress tests (tensile strength, elongation) conforming to ASTM standards.
- Defined leak test protocols.
- Biocompatibility tests (dermal irritation, sensitization) following established methodologies.
- Chemical analysis (residual protein level) using ASTM D 5712-95.
These are all objectively quantifiable and do not rely on expert consensus or pathology in the typical sense of medical imaging.
8. Sample Size for the Training Set
- Not applicable. The concept of a "training set" applies to machine learning algorithms, which are not described here.
9. How Ground Truth for the Training Set Was Established
- Not applicable. As above, there is no AI training set.
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APPENDIX F
510(k) SUMMARY
SUMMARY OF THE SAFETY AND EFFECTIVENESS FOR ROYAL SHIELD BLUE COLORED POWDERED LATEX EXAMINATION GLOVES WITH AND WITHOUT BUBBLEGUM SCENTING & A PROTEIN LABELLING CLAIM
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 - ROY AL SHIELD COLORED POWDERED LATEX EXAMINATION GLOVES Common Name - Exam gloves
Classification Name - Patient examination glove (per 21 CFR 880.6250)
Classification Information - Class I latex patient examination glove 80LYY, powdered and meeting all the requirements of ASTM-D3578-99 Standard Specification for Latex Examination Gloves for Medical Application.
Device Description:
Class I latex patient examination gloves 80LYY, powdered and meeting all the requirements of ASTM-D3578-99 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.
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 | |||
|---|---|---|---|
| Width | Ambidextrous | Size Fitted | |
| X-Small 70 mm +/- 10 mmSmall 80 mm +/- 10mmMedium 95 mm +/- 10mmLarge 111mm +/- 10mm | 5.5 70 +/- 10 mm6.0 76 +/- 10mm6.5 83 +/- 10mm7.0 89 +/- 10mm7.5 95 +/- 10mm8.0 102 +/- 10mm8.5 108 +/- 10 mm9.0 114 +/- 10mm | ||
| Length | 230 mm | ||
| Thickness - | FingerPalm | 0.08 mm min0.08 mm min |
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| DATETESTED | TENSILE STRENGTH | ULTIMATE ELONGATION | ||||||
|---|---|---|---|---|---|---|---|---|
| AGED | UNAGED | AGED | UNAGED | |||||
| SHIELD | ASTM | SHIELD | ASTM | SHIELD | ASTM | SHIELD | ASTM | |
| 20 May 99 | 27.7 | 14.0 | 24.3 | 14.0 | 950 | 500 | 900 | 700 |
| 20 May 99 | 25.2 | 14.0 | 30.3 | 14.0 | 900 | 500 | 900 | 700 |
| 20 May 99 | 29.1 | 14.0 | 30.1 | 14.0 | 950 | 500 | 900 | 700 |
2. Physical Properties (ASTM-D3578-99 Standard Specification for Latex Exam Gloves)
3. Water Tight Test Results*
| BATCH # | DATETESTED | SAMPLE SIZE | LEAK STATUS | NUMBERLEAKED |
|---|---|---|---|---|
| 9028-9035 S | 15 May 99 | 315 | Yes | 4 |
| 9030-9036 M | 19 May 99 | 315 | Yes | 7 |
| 9027-9031 L | 19 May 99 | 200 | Yes | 3 |
-
APO3151/52
The above figures are within the ASTM D-3578-99 requirements for latex exam gloves of 2.5% AQL.
4. Biocompatibility
The test results below show that the gloves meet FDA biocompatibility requirements:
BIOCOMPATIBILITY TESTS
Primary Dermal Irritation Test
Skin Sensitization Study
RESULTS
Not a primary irritant
Not a sensitiser
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5. Residual Protein Level
| TESTS | FDA ALLOWABLE LEVEL | CLAIMED LEVEL |
|---|---|---|
| ASTM D 5712-95 | - | < 200 µg/gRange:Mean: |
The data presented indicate that the Royal Shield Powdered latex examination glove
-
- meets/exceeds ASTM- D3578-99 Standard Specifications For Latex Examination Glove,
-
- meets FDA pinhole requirements,
-
- meets the protein labeling claim level at <200 µg/g.
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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle's head and three stripes.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 3 1999
Shield Gloves Manufacturer (M) Sdn. Bhd. C/O Mr. E. J. Smith Consultant Smith Associates P.O. Box 4341 Crofton, Maryland 21114
K992419 Re : Royal Shield Non-Sterile Blue Powdered Latex Trade Name: Examination Gloves with Protein Content Labeling Claim (200 Micrograms or Less of Total Water Extractable Protein per gram) with or without Bubble Gum Scent Requlatory Class: I Product Code: LYY July 16, 1999 Dated: Received: July 20, 1999
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, 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 registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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 requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your
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Page 2 - Mr. Smith
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 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 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 one regulation entitled, "Misbranding by reference to
the regulation entitled, "Misbranding (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
y A. Ulatowsk Timoth Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
Applicant: Shield Gloves Manufacturer (M) Sdn Bhd
510K Number: K992419
Device Name: Royal Shield Powdered Latex Examination Gloves Dolor Will our Willi Rusbile Gurn SunT, Ontains 200 mcqm or less of Total Wefer of hockable
Indications For Use 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) | |
|---|---|
| (Division Sign-off) | |
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K992419 |
Prescription Use ......................... OR Over-The-Counter........................ 
Per 21 CFR 801.109
§ 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.