(59 days)
Not Found
Not Found
No
The device description and performance studies focus on the physical properties and barrier function of examination gloves, with no mention of AI or ML.
No
The device, an examination glove, is intended for preventing contamination, not for treating or curing a medical condition.
No
The device is described as a glove worn on the examiner's hand or finger to prevent contamination, which is a physical barrier function, not a diagnostic one.
No
The device description clearly states it is a physical product (gloves) and the performance studies focus on physical properties and testing, not software validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device 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." This describes a barrier device used for infection control, not a device used to examine specimens derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of disease or impairment.
- Device Description: The description reinforces the intended use as a barrier device.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing diagnostic information
- Using reagents or assays
The performance studies and key metrics listed are related to the physical properties and safety of the glove as a barrier, not its ability to perform an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
A powder-free 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.
Product codes (comma separated list FDA assigned to the subject device)
LZA
Device Description
Black Nitrile Examination Gloves, Powder Free, Non Sterile
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)
Performance test data of the non-clinical tests include:
- Physical Dimension: Length = 240.9 mm, Width = 97.7 mm, Thickness (Finger = 0.148 mm, Palm = 0.109 mm, Cuff = 0.092 mm). Specification: Length >= 230 mm, Width = 95 + 10, Thickness >= 0.05.
- Physical Properties: Unaged (TS = 18.8 MPa, UE = 679.4 %), Aged (TS = 21.3 MPa, UE = 767.4 %). Specification for Unaged: TS = 14 MPa, UE = 500 %; for Aged: TS = 14 MPa, UE = 400 %.
- Freedom from Pinholes: Acc / Rej = 3 / 4.
- Moisture Content: 0.46%. Specification: 0.8%.
- Powder Residue: 0.96 mg/glove. Specification:
§ 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
K0904664
Image /page/0/Picture/1 description: The image shows a stylized, black and white graphic of the letters 'MB' in a gothic or old English font. The letters are large and bold, with intricate details and serifs characteristic of this type of font. The overall impression is one of formality and tradition.
.. - .
PT. MAHAKARYA INTI BUANA
Jalan Sei Belumai Desa Dalu 10 A Dusun 1 No. 18 Tanjung Morawa – 20362
SUMUT – INDONESIA
Tel +62-61-30007150, 51, 52, 53
Fax +62-61-30007156
Date : February 10, 2009
510 (K) SUMMARY
APR 2 3 2009
| 1.0 | Submitter: | ||
|---|---|---|---|
| Name | PT MAHAKARYA INTI BUANA | ||
| Address | Jl. Sei Belumai, Desa Dalu 10 A Dusun I No. 18 | ||
| Tanjung Morawa – 20362 | |||
| SUMUT – INDONESIA | |||
| Phone No. | +62-61-30007150, 51 | ||
| Fax No. | +62-61-30007156 | ||
| FDA Registration No : | 3004049816 | ||
| 2.0 | Contact Person: | ||
| Name | (Mr) Azman Ismail | ||
| Phone | +62-61-30007150,51 | ||
| Fax No. | +62-61-30007156 | ||
| qa@mib-ia.com | |||
| 3.0 | Name of the device: | ||
| Trade Name | 1) Senstouch and | ||
| 2) Multiple or Customers' Trade Name | |||
| Device Name | Black Nitrile Examination Gloves, Powder Free, | ||
| Non Sterile | |||
| Common Name | Patient Examination Gloves | ||
| Classification Name | Nitrile Examination Gloves | ||
| 4.0 | Identification of The Legally Marketed Device: | ||
| Polymer | Nitrile Latex | ||
| Device Class | Class I | ||
| Substantial Equivalent | |||
| Device Description | Patient Examination Gloves, 21 CFR 880.6250 | ||
| Product Code | Nitrile - 80LZA | ||
| Standard | ASTM D 6319-00a (2005) | ||
| 5.0 | Performance Testing Standard: | ||
| Water Leak Test | G-I, AQL 1.5 | ||
| Physical Dimension | S-2, AQL 4.0 | ||
| Physical Properties | S-2, AQL 2.5, Single Sampling | ||
| Residual Powder | N = 5 | ||
| Moisture Content | N=8 | ||
| Visual Inspection | Critical Defects | AQL 0.65 | |
| Major Defects | AQL 2.5 | ||
| Minor Defects | AQL 4.0 | ||
Page 1 of 3
1
Image /page/1/Picture/0 description: The image shows a stylized, gothic-style monogram consisting of the letters 'M' and 'B'. The letters are rendered in a bold, black color with intricate details and sharp edges, giving them a medieval or old-world appearance. The 'M' and 'B' are intertwined, creating a unified design that could be used as a logo or emblem. The overall impression is one of classic elegance and historical significance.
PT. MAHAKARYA INTI BUANA
Jalan Sei Belumai Desa Dalu 10 A Dusun 1 No. 18 Tanjung Morawa -- 20362 SUMUT - INDONESIA
Tel +62-61- 30007150, 51, 52, 53 Fax +62-61-30007156
6.0 Intended Use of The Device
Powder-free Black Nitrile Examination Gloves, Non Sterile is a disposable device intended for medical purposes that is worn on the examiner's to prevent contamination between patient and examiner.
7.0 Summary of The Technological Characteristics of The Device (Performance and Conformance Test Data):
Technological characteristics of Black Nitrile Examination Gloves, Powder Free, Non Sterile are summarized as below:-
| REFERENCE | DEVICE | STANDARD | |
|---|---|---|---|
| REQUIREMENT | STANDARDS | PERFORMANCE | SPECIFICATION |
| Physical Dimension | D 6319-00aE3 | Length = 240.9 mm | |
| Width = 97.7 mm | |||
| Thickness: |
- Finger = 0.148 mm
- Palm = 0.109 mm
- Cuff = 0.092 mm | Length $\geq$ 230 mm
Width = 95 + 10
Thickness $\geq$ 0.05 |
| Physical Properties | D 6319-00aE3 | Unaged:
TS = 18.8 MPa
UE = 679.4 %
Aged:
TS = 21.3 MPa
UE = 767.4 % | Unaged:
TS = 14 MPa
UE = 500 %
Aged:
TS = 14 MPa
UE = 400 % |
| Freedom from Pinholes | D 6319-00aE3
FDA 21 CFR
800.20 | | Acc / Rej = 3 / 4 |
| Moisture Content | In-house | 0.46% | 0.8% |
| Powder Residue | D 6319-00aE3
D6124 - 01 | 0.96 mg/glove |