(228 days)
Not Found
No
The device is a standard examination glove and the summary contains no mention of AI, ML, or related concepts.
No.
The device is described as a "barrier against potentially infectious materials and other contamination," which is a protective function, not a therapeutic one aiming to treat or prevent a disease/condition.
No
The device is described as an examination glove intended as a barrier, not for diagnosing any medical condition.
No
The device is described as "Blue Powdered Latex Examination Gloves," which are physical gloves made from natural rubber latex. The description and performance studies focus on physical properties and biocompatibility, not software functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "barrier against potentially infectious materials and other contamination" when worn on the hands. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description is for "Latex Patient Examination Gloves," which are a physical barrier device.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
- Using reagents or assays
The information provided focuses on the physical properties and performance of the gloves as a barrier, not on any diagnostic capabilities.
N/A
Intended Use / Indications for Use
Blue Powdered Latex Examination Gloves, Non-sterile is a disposable medical device made from natural rubber latex compound. It is intended to be worn on the hands as barrier against potentially infectious materials and other contamination.
Product codes
LYY
Device Description
Latex Patient Examination Gloves, LYY, Powdered
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare 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)
Quality Performance of gloves based on the requirements stated in item 6. (ASTM D 3578-01 Standard and FDA's requirement)
Water Leak Test: Pass GI, AQL 1.5
Length (mm): Minimum 290 mm for all sizes
Palm Width (mm): 75-78 (XS), 82-86 (S), 92-95 (M), 103-109 (L), 111-115 (XL)
Thickness (mm) (Single layer): Finger Min 0.10, Palm Min 0.10
Physical Properties Before Ageing: Tensile Strength Min 18 MPa, Ultimate Elongation Min 700 %
Physical Properties After Ageing: Tensile Strength Min 14 MPa, Ultimate Elongation 500 %
Powder Content: Below 10.0 mg/glove (ASTM 6124)
Protein Content: Below 200 µg/dm² (ASTM 5712)
Biocompatibility Test: Primary Dermal Irritation Study and Dermal Sensitization Study, passed both.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
17.0 SMDA 510(K) SUMMARY
APR 1 3 2007
| 1. | Applicant | : | MULTISAFE SDN. BHD
Lot 764, Bidor Industrial Estates,
35500 Bidor,
Perak Darul Ridzuan,
Malaysia. |
|----|--------------------------|---|---------------------------------------------------------------------------------------------------------------|
| | Tel No. | : | 605-4348269 |
| | Fax No | : | 605-4348266 |
| | Name of Contact Person | : | 1. Mr. Abd Hadi bin Husin
2. Ms. Rosnani Binti Hassan Besari |
| | Date of Summary Prepared | : | 28th February 2007 |
| 2. | Name of Device | | |
| | Trade Name | : | Blue Powdered Latex Examination
Glove, Non-Sterile |
| | Common Name | : | Examination Gloves |
| | Classification Name | : | Patient Examination Gloves (Class 1 in
US and European markets, Class IIa in
Canadian Market) |
3. Identification Of the Legally Marketed Devices
Latex Patient Examination Gloves LYY, Powdered that meets all the requirements of FDA, ASTM D 3578, ISO 11193, EN 455 : Part 1, Part 2 and Part 3, CMDR, MDR and CGSB.
.
1
Description Of the Devices 4.
Latex Patient Examination Gloves, LYY, Powdered
5. The Intended Use of Glove
A medical glove is worn on the hands of healthcare and similar personnel as a barrier against potentially infectious materials and other contamination between healthcare and patient's body, fluid, waste or environment.
- The Quality performance of the glove are shown in the table above (. meets ASTM D 3578-01 Standard and FDA's requirement
- The Biocompatibility Test consists of Primary Dermal Irritation Study 7. And the Dermal Sensitization Study. The gloves pass the Biocompatibility Test.
2
Summary of Quality Performance 8.
...
!
:
The Quality Performance of gloves based on the requirements stated in item 6.
| TEST | REQUIREMENT | IN-HOUSE QUALITY
PERFORMANCE |
|-------------------------------------|--------------|---------------------------------|
| 1. Water Leak Test
(1000ml) | GII, AQL 2.5 | Pass GI, AQL 1.5 |
| 2. Length (mm)
Size: XS | Min. 220 | Minimum 290 mm for all
sizes |
| S | Min. 230 | |
| M | Min 230 | |
| L | Min 230 | |
| XL | - | |
| 3 Palm Width (mm)
Size : XS | $70\pm10$ | 75-78 |
| S | $80\pm10$ | 82-86 |
| M | $90\pm10$ | 92-95 |
| L | $100\pm10$ | 103-109 |
| XL | - | 111-115 |
| 4. Thickness (mm)
(Single layer) | | |
| Finger | Min 0.08 | Min 0.10 |
| Palm | Min 0.08 | Min 0.10 |
| 5. Physical
Properties | | |
| Before Ageing | | |
| Tensile Strength (MPa) | Min. 14 | Min 18 |
| Ultimate Elongation (%) | Min 700 | Min 700 |
| After Ageing | | |
| Tensile Strength (MPa) | Min.14 | Min. 14 |
| Ultimate Elongation (%) | 500 | 500 |
| 6. Powder Content | ASTM 6124 | Below 10.0 mg/glove |
| 7. Protein Content | ASTM 5712 | Below 200 µg/dm² |
14
. . .
3
Conclusion 9.
We concluded that the Blue Powdered Latex Examination Gloves, Protein Content Labeling (200 µg/dm2 or less), Non-Sterile meets:
- ASTM D3578 Standard
- · FDA pin hole requirement
- FDA minimum powder residual content
- · CMDR requirement
- CGSB requirement
- · Label Claim of 200 µg/dm2 or less of total water extractable protein content
4
......
. Comparison table and discussion of the similarities and difference of Blue Powdered Latex :amination Gloves (Non-Sterile) compared to Multisafe Powdered Latex Examination Gloves, (Non-.. erile).
| No | Description | Requirement | 510K No | |
|---|---|---|---|---|
| K993811 | K062526 | |||
| 1 | Water Tight Test | |||
| (1000ml) | GII, AQL 2.5 | Pass GI, AQL 1.0 | Pass GI, AQL 1.5 | |
| 2 | Dimension Test | Min. 290 (Long Glove) | ||
| Min. 230 (Short Glove) | Min 230 for all sizes | Min 290 for all sizes | ||
| 3 | Palm Width (mm) | XS : 70 +/- 10 | ||
| S : 80 +/- 10 | ||||
| M : 90 +/- 10 | ||||
| L :100 +/- 10 | Meet the specification | Meet the specification | ||
| 4 | Thickness (mm) | |||
| i) Finger | ||||
| ii) Palm | Min. 0.08 | |||
| Min. 0.08 | Meet the specification | Meet the specification | ||
| 5 | Physical Properties (Before | |||
| Aging) | ||||
| i) Tensile Strength | ||||
| (Mpa) | Min 14 | Min 18 | Min. 18 | |
| ii) Ultimate | ||||
| Elongation (%) | Min. 700 | Min. 700 | Min. 700 | |
| Physical Properties | ||||
| (After Aging) | ||||
| i) Tensile Strength | ||||
| (Mpa) | Min. 14 | Min. 14 | Min. 14 | |
| ii) Ultimate | ||||
| Elongation (%) | Min. 500 | Min. 500 | Min. 500 | |
| 6 | Powder Content | ASTM 6124 | Meet the specification | Below 10.0mg/glove |
| 7 | Protein Content | ASTM 5712 | Meet the specification | Below 200 µg/dm² |
| 8 | Biocompatibility Test | |||
| i) Primary Skin | ||||
| Irritation | No Animal Irritation | Yes | Yes | |
| ii) Dermal | ||||
| Sensitization Assay | ||||
| (Animal Study) | No Animal Irritation | Yes | Yes | |
| 9 | Colour Extraction | Others | Normal Creamy | |
| White | Blue Colour | |||
| 10 | Ingredient | |||
| a) Latex | ||||
| b) Accelerators | ||||
| c) Antioxidant | ||||
| d) Curing Agent | ||||
| e) Activator | Natural Rubber latex | |||
| ZDBC | ||||
| ZDEC | ||||
| Sulphur | ||||
| Zinc Oxide | √ | √ | ||
| f) Dispersing Agent | ||||
| g) Filler / Pigment | ||||
| h) Donning Powder | ||||
| i) Pigment | Tamol | |||
| Titanium Dioxide | ||||
| Modified Corn Starch | ||||
| Flexobrite Blue | ||||
| √ | ||||
| √ | ||||
| √ | ||||
| X | √ | |||
| √ | ||||
| √ | ||||
| √ |
1 ୧
5
:
:
Conclusion :
125
P
1
e Blue Powdered Latex Examination Gloves (Non-Sterile) is similar with Multisafe Powdered Latex Examination Gloves (Non-Sterile) except the dimension of length and colour extraction (
MULTISAFE SDN. BHDA
R ABD HADI HUSIN (Plant Mahager)
। ।
6
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it, and three parallel lines above it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 3 2007
Mr. Abd Hadi Bin Husin Quality Management Representative/Plant Manager Multisafe Sdn Bhd Lot 764, Bidor Industrial Estate 35500 Bidor Perak Darul Ridzuan MALAYSIA
Re: K062526
Trade/Device Name: Blue Powdered Latex Examination Gloves, Non-Sterile Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: February 14, 2007 Received: March 19, 2007
Dear Mr. Husin:
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.
7
Page 2 - Mr. Husin
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.
Sincerely yours,
Sylitte Y. Micham Om.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
Indications for Use
510(k) Number (if known): K062526
Device Name: Blue powdered latex Examination Gloves, Non-sterile
Indications For Use:
Blue Powdered Latex Examination Gloves, Non-sterile is a disposable medical device made from natural rubber latex compound. It is intended to be worn on the hands as barrier against potentially infectious materials and other contamination.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Stales H.M. Murphy, bo
(K) Number K 062526
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