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K Number
K111300
Device Name
SENSTOUCH NITRILE EXAMINATION GLOVES, POWDER FREE, NON STERILE (GREEN, ORANGE, VIOLET AND WHITE)
Manufacturer
PT. MAHAKARYA INTI BUANA
Date Cleared
2011-08-12

(95 days)

Product Code
LZA
Regulation Number
880.6250
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Green, Orange, Violet and White Nitrile examination gloves, Powder Free, Non - Sterile are disposable device and made of Synthetic Polymer that exhibits rubber like characteristics intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Powder Free Green, Orange, Violet and White 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.
More Information

Not Found

Not Found

No
The device is a simple examination glove and the summary describes standard performance testing for such devices, with no mention of AI or ML.

No
The device, examination gloves, is intended to prevent contamination, not to treat or alleviate a medical condition.

No

The device is described as an examination glove intended to prevent contamination, not to diagnose a condition.

No

The device is described as physical examination gloves made of synthetic polymer, clearly indicating it is a hardware device and not software.

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 patient and examiner by being worn on the hand or finger. This is a physical barrier function.
  • Device Description: The description reinforces the physical barrier function.
  • Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. IVDs typically involve analyzing biological samples.
  • Performance Studies: The performance studies focus on physical properties, freedom from pinholes, moisture content, powder residue, and biocompatibility – all related to the physical integrity and safety of the glove as a barrier. There are no studies related to diagnostic accuracy or analysis of biological samples.

Therefore, this device falls under the category of a medical device used for protection and barrier purposes, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

"Powder Free Green, Orange, Violet and White 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."

"Green, Orange, Violet and White Nitrile examination gloves, Powder Free, Non - Sterile are disposable device and made of Synthetic Polymer that exhibits rubber like characteristics intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner."

Product codes

LZA

Device Description

"Nitrile Examination Gloves, Powder Free, Non Sterile (Green, Orange, Violet and White)"

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

"the examiner" - implies a medical professional or caregiver in a medical setting.

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 non-clinical tests include:
Water Leak Test: G-1, AQL 1.5, 0 piece found (meets Acc / Rej = 3 / 4)
Physical Properties: S-2, AQL 4.0; S-2, AQL 2.5, Single Sampling
Residual Powder: N = 5, 0.84 mg/glove (meets

§ 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

K111300

AUG 1 2 2011

Image /page/0/Picture/2 description: The image shows a stylized logo with the letters 'MB' in a bold, gothic-style font. The letters are interconnected and have a textured appearance, giving them a three-dimensional effect. A horizontal line runs through the middle of the letters, adding a graphic element to the design. The overall impression is one of a strong, established brand or organization.

PT. MAHAKARYA INTI BUANA

Jl .Desa Dalu X-A, Dalu 10
Deli Serdang – T. Morawa
Sumatera Utara – 20362
Indonesia

Tel +62-61- 30007150, 51, 52, 53 Fax +62-61-30007156

Date : May 3, 2011

510 (K) SUMMARY

1.0Submitter:
Name:PT MAHAKARYA INTI BUANA
Address:Jl. Desa Dalu X-A, Dalu 10
Deli Serdang - T. Morawa
Sumatera Utara - 20362
Phone No.:+62-61-30007150, 51
Fax No.:+62-61-30007156
FDA Registration No:3005813621
2.0Contact Person:
Name:(Ms) Lina Ng
Phone:+62-61-30007150,51
Fax No.:+62-61-30007156
E-mail:qa@mhk-ia.com
3.0Name or The Device:
Trade Name:1) Senstouch and
  1. Multiple or Customers' Trade Name |
    | | Device Name | : | Nitrile Examination Gloves, Powder Free, Non Sterile
    (Green, Orange, Violet and White) |
    | | 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-1, AQL 1.5 |
    | | Physical Properties | : | 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 Defect AQL 0.65
    Major Defect AQL 2.5
    Minor Defect AQL 4.0 |
    | | REFERENCE | DEVICE | STANDARD |
    | REQUIREMENT | STANDARDS | PERFORMANCE | SPECIFICATION |
    | Physical Dimension | D 6319-00aE3 | Length = 246.77 mm
    Width = 94.46 mm
    Thickness:
  • Finger = 0.150 mm
  • Palm = 0.095 mm
  • Cuff = 0.082 mm | Length ≥ 230 mm
    Width = 95 ± 10
    Thickness ≥ 0.05 |
    | Physical Properties | D 6319-00aE3 | Unaged:
    TS = 15.9 MPa
    UE = 583.4%
    Aged:
    TS = 22.3 MPa
    UE = 569.2 % | Unaged:
    TS = 14 MPa
    UE = 500 %
    Aged:
    TS = 14 MPa
    UE = 400 % |
    | Freedom from Pinholes | D 6319-00aE3
    FDA 21 CFR
    800.20 | 0 piece found | Acc / Rej = 3 / 4 |
    | Moisture Content | In-house | 0.67% | 0.8% |
    | Powder Residue | D 6319-00aE3
    D6124 - 01 | 0.84 mg/glove |