(55 days)
Not Found
Not Found
No
The device is a standard medical glove with no mention of AI/ML capabilities or related performance metrics.
No.
The device is a medical glove designed to prevent contamination, not to treat a disease or condition.
No
The device, a medical glove, is intended to prevent contamination and is not described as diagnosing any condition or disease.
No
The device description clearly states it is a physical medical glove made of latex, which is a hardware component.
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: The device is described as a Class I latex patient examination glove meeting ASTM standards. This aligns with a physical barrier device, not a diagnostic instrument or reagent.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies focus on physical properties (water tightness) and biocompatibility (skin irritation/sensitization), which are relevant to a barrier device, not an IVD.
IVDs are devices intended for use in vitro for the examination of 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 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
LYY
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.
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)
- Dimension:
- Width: X-Small 70 mm +/- 10 mm, Small 80 mm +/- 10mm, Medium 95 mm +/- 10mm, Large 111mm +/- 10mm. Size Fitted: 5.5 70 +/- 10 mm, 6.0 76 +/- 10mm, 6.5 83 +/- 10mm, 7.0 89 +/- 10mm, 7.5 95 +/- 10mm, 8.0 102 +/- 10mm, 8.5 108 +/- 10 mm, 9.0 114 +/- 10mm.
- Length: 230 mm.
- Thickness: Finger 0.08 mm min, Palm 0.08 mm min.
- Physical Properties (ASTM-D3578-99 Standard Specification for Latex Exam Gloves):
- Tensile Strength (aged/unaged) and Ultimate Elongation (aged/unaged) values tested on May 20, 1999, showing compliance with ASTM standards.
- Water Tight Test Results:
- Batch #9028-9035 S: Tested May 15, 1999, sample size 315, 4 leaked.
- Batch #9030-9036 M: Tested May 19, 1999, sample size 315, 7 leaked.
- Batch #9027-9031 L: Tested May 19, 1999, sample size 200, 3 leaked.
- Figures are within the ASTM D-3578-99 requirements for latex exam gloves of 2.5% AQL.
- Biocompatibility:
- Primary Dermal Irritation Test: Not a primary irritant.
- Skin Sensitization Study: Not a sensitiser.
- Residual Protein Level:
- ASTM D 5712-95: Claimed 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 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 mm | |||
| Small 80 mm +/- 10mm | |||
| Medium 95 mm +/- 10mm | |||
| Large 111mm +/- 10mm | 5.5 70 +/- 10 mm | ||
| 6.0 76 +/- 10mm | |||
| 6.5 83 +/- 10mm | |||
| 7.0 89 +/- 10mm | |||
| 7.5 95 +/- 10mm | |||
| 8.0 102 +/- 10mm | |||
| 8.5 108 +/- 10 mm | |||
| 9.0 114 +/- 10mm | |||
| Length | 230 mm | ||
| Thickness - | Finger | ||
| Palm | 0.08 mm min | ||
| 0.08 mm min |
1
| DATE
| TESTED | 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 # | DATE
TESTED | SAMPLE SIZE | LEAK STATUS | NUMBER
LEAKED |
|-------------|----------------|-------------|-------------|------------------|
| 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 |
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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
2
5. Residual Protein Level
| TESTS | FDA ALLOWABLE LEVEL | CLAIMED LEVEL |
|---|---|---|
| ASTM D 5712-95 | - | |
| (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