(76 days)
Not Found
Not Found
No
The summary describes a standard examination glove and makes no mention of AI or ML technology.
No
The device, a polymer-coated latex examination glove, is intended for preventing contamination between patient and examiner, not for treating a disease or condition.
No
Explanation: The device is described as a "Polymer Coated Latex Examination Glove," intended to "prevent contamination between patient and examiner." Its function is protective, not diagnostic.
No
The device is a physical glove made of latex and polymer, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to prevent contamination between patient and examiner by being worn on the hand or finger. This is a physical barrier function, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description focuses on material composition and performance standards related to physical properties (like leak testing). It doesn't mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The document lacks any mention of:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
- Reagents, calibrators, or controls typically associated with IVDs
This device is clearly described as a medical device (specifically, an examination glove) used for barrier protection, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Polymer Coated Latex Examination Glove, Powder Free, Non Sterile is a disposable device and made of Natural Rubber Latex Coated with Polymer Intended for Medical purpose that is worn on the Examiner's hand or finger to prevent contamination between patient and examiner
Product codes (comma separated list FDA assigned to the subject device)
LYY
Device Description
The Polymer Coated Latex Examination Gloves, Powder Free, Non Sterile meets all the requirements of ASTM standard D 3578-01 a22 and FDA 1000 ml Water Leak Test.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand or finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner
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)
The Polymer Coated Latex Examination Gloves, Powder Free, Non Sterile are summarized with the following technological characteristics compared to ASTM equivalent standards:
- Dimension: Meets D 3587 -01 ae²
- Physical Properties: Meets D 3587 -01 ae²
- Freedom from Pinholes: Meets D 3587 -01 ae² and FDA 21 CFR 800.20
- Powder Free Residue:
§ 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
Image /page/0/Picture/0 description: The image shows the letterhead for PT Mandiri Inti Buana. The letterhead includes the company name, address (Jalan Sei Belumai, Desa Dalu 10 A Dusun 1, Tanjung Morawa - 20362, SUMUT - INDONESIA), telephone number (+62-61-7944880), and fax number (+62-61-7944882). The date "OCT - 6 2005" is also present, along with the number K051987.
510 (K) SUMMARY
| 1.0 | Submitter: | ||
|---|---|---|---|
| Name | : | PT MANDIRI INTI BUANA | |
| Address | : | Jl. Sei Belumai, Desa Dalu 10 A Dusun 1 | |
| Tanjung Morawa -- 20362 | |||
| SUMUT - INDONESIA | |||
| Phone No. | : | +62-61-7944880 | |
| Fax No. | : | +62-61-7944882 | |
| Date of Summary Prepared | : |
2.0 Contact Person:
| Name | : | Mr. Sasitharan Nair |
|---|---|---|
| Phone | : | +62-61-7944880 |
| Fax No. | : | +62-61-7944882 |
3.0 Name or the device:
| Trade Name | 1) Flexiskin and
2) Multiple or Customers' Trade Name |
|---------------------|----------------------------------------------------------------------|
| Device Name | Polymer Coated Latex Examination Gloves, Powder
Free, Non Sterile |
| Common Name | Examination Gloves |
| Classification Name | Patient Examination Gloves (Class I) |
Identification of The Legally Marketed Device: 4.0
Class I Examination gloves, 80 LYY, Powder Free, that meets all the requirements of ASTM standard D 3578-01 a22 and FDA 1000 ml Water Leak Test.
Description of The Device 5.0
The Polymer Coated Latex Examination Gloves, Powder Free, Non Sterile mects all the requirements of ASTM standard D 3578-01 a22 and FDA 1000 ml Water Leak Test.
Intended Use of The Device 6.0
The Polymer Coated Latex Examination Glove, Powder Free, Non Sterile is a disposable device intended for medical purposes that is worn on the examiner's to prevent contamination between patient and examiner.
1
Image /page/1/Picture/0 description: The image shows a stylized logo or emblem consisting of the letters "MB" in a bold, gothic-style font. The letters are rendered in solid black, creating a strong contrast against the white background. The design appears to be hand-drawn or digitally created to mimic a hand-drawn aesthetic, with irregular edges and thick strokes that give it a somewhat rough and edgy appearance. The overall impression is that of a logo for a brand or organization with a bold, somewhat aggressive identity.
PT MANDIRI INTI BUANA
Jalan Sei Bclumai Desa Dalu 10 A Dusun 1 Taniung Morawa -- 20362 SUMUT - INDONESIA
+62-61-7944880 ان ا 162-61-7944882 Fax
7.0 Summary of The Technological Characteristics of The Device The Polymer Coated Latex Examination Gloves, Powder Free, Non Sterile are summarized with the following technological characteristics compared to ASTM equivalent standards.
| CHARACTERISTICS | STANDARDS | DEVICE
PERFORMANCE |
|----------------------------------|---------------------------------------|----------------------------------------|
| Dimension | D 3587 -01 ae² | Meets |
| Physical Properties | D 3587 -01 ae² | Meets |
| Freedom from Pinholes | D 3587 -01 ae²
FDA 21 CFR 800.20 | Meets |
| Powder Free Residue | D 3587 -01 ae²
D6124 - 01 | Polymer Coated Latex Examination Glove, Powder Free, Non Sterile is a disposable device and made of Natural Rubber Latex Coated with Polymer Intended for Medical purpose that is worn on the Examiner's hand or finger to prevent contamination between patient and examiner
Prescription Use __ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use
(21 CFR 801 Subpart C) CRF801.109
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shilu A. Murphy, MD 11/4/15
(Division Sign Off)
(Division Sign-Off) Division of Anesthesiology, General Hospita Infection Control, Der
510(k) Number: N051987
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