(106 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This glove has been tested for use with specific chemotherapy drugs listed below.
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Powder Free Nitrile Patient Examination Glove, Orange Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs meet all of the requirements of ASTM D6319-10. The gloves are ambidextrous single-use disposable devices that come in five sizes (XS, S, M, L, XL) in blue or orange color.
The provided document is a 510(k) Premarket Notification for Powder Free Nitrile Patient Examination Gloves. This type of device is a physical product and does not involve AI/ML. Therefore, many of the requested categories in the prompt are not applicable.
Here's the information that can be extracted relevant to the performance of these gloves:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Standards Requirements) | Reported Device Performance (Results Summary) | Conclusion |
|---|---|---|---|
| Dimensions | ASTM D6319-10 (Length ≥ 270mm, Palm Thickness ≥ 0.10mm, Finger Thickness ≥ 0.10mm, Specific Widths for XS-XL) | - Length ≥ 270mm - Palm Thickness ≥ 0.10mm - Finger Thickness ≥ 0.10mm - Widths: X-Small 70-80mm, Small 80-90mm, Medium 90-100mm, Large 101-111mm, X-Large ≥ 111mm | Meets Standard Requirements |
| Physical Properties | ASTM D6319-10 (Before Aging: Tensile Strength ≥ 14 MPA, Elongation > 500%; After Aging: Tensile Strength ≥ 14 MPA, Elongation > 400%) | - Before Aging: Tensile Strength ≥ 14 MPA, Elongation > 500% - After Aging: Tensile Strength ≥ 14 MPA, Elongation > 400% | Meets Standard Requirements |
| Freedom from Pinholes | ASTM D5151-11, ASTM D6319-10 (Pass quality level at G1 AQL 1.5) | Tested in accordance with ASTM D5151 test method. Pass quality level at G1 AQL 1.5 | Meets Standard Requirements |
| Powder Free Residue | ASTM D6124-11, ASTM D6319-10 (≤ 2 mg of residual powder per glove) | Result generated values ≤ 2 mg of residual powder per glove | Meets Standard Requirements |
| Biocompatibility (Dermal Sensitization) | ISO 10993-10:2010 (Not a contact skin sensitizer) | Not a contact skin sensitizer | Meets Standard Requirements |
| Biocompatibility (Primary Skin Irritation Test) | ISO 10993-10:2010 (Not a primary skin irritant) | Not a primary skin irritant | Meets Standard Requirements |
| Chemotherapy Drug Permeation (Blue Glove) | ASTM D6978-05 (Minimum Breakthrough Detection Time in Minutes) | Carmustine (3.3 mg/ml): 15.1 Cisplatin (1.0 mg/ml): >240 Cyclophosphamide (20 mg/ml): >240 Cytarabine (100 mg/ml): >240 Dacarbazine (DTIC) (10.0 mg/ml): >240 Doxorubicin Hydrochloride (2.0 mg/ml): >240 Etoposide (20.0 mg/ml): >240 Fluorouracil (50.0 mg/ml): >240 Ifosfamide (50.0 mg/ml): >240 Methotrexate (25 mg/ml): >240 Mitomycin C (0.5 mg/ml): >240 Mitoxantrone (2.0 mg/ml): >240 Paclitaxel (Taxol) (6.0 mg/ml): >240 Thiotepa (10.0 mg/ml): >240 Vincristine Sulfate (1.0 mg/ml): >240 | Tested for Use with Chemotherapy Drugs. Carmustine has extremely short permeation times of 15.1 minutes. |
| Chemotherapy Drug Permeation (Orange Glove) | ASTM D6978-05 (Minimum Breakthrough Detection Time in Minutes) | Carmustine (3.3 mg/ml): 17.9 Cisplatin (1.0 mg/ml): >240 Cyclophosphamide (20 mg/ml): >240 Cytarabine (100 mg/ml): >240 Dacarbazine (DTIC) (10.0 mg/ml): >240 Doxorubicin Hydrochloride (2.0 mg/ml): >240 Etoposide (20.0 mg/ml): >240 Fluorouracil (50.0 mg/ml): >240 Ifosfamide (50.0 mg/ml): >240 Methotrexate (25 mg/ml): >240 Mitomycin C (0.5 mg/ml): >240 Mitoxantrone (2.0 mg/ml): >240 Paclitaxel (Taxol) (6.0 mg/ml): >240 Thiotepa (10.0 mg/ml): >240 Vincristine Sulfate (1.0 mg/ml): >240 | Tested for Use with Chemotherapy Drugs. Carmustine has extremely short permeation times of 17.9 minutes. |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify a numerical sample size for the various tests (Dimensions, Physical Properties, Freedom from Pinholes, Powder Free Residue, Biocompatibility, Chemotherapy Drug Permeation). It generally refers to testing "in accordance with" the various ASTM and ISO standards, which inherently include sampling plans. For instance, "Pass quality level at G1 AQL 1.5" for pinholes refers to a specific sampling plan within ASTM D5151.
- Data Provenance: The document implies that testing was conducted by the manufacturer, Top Calibre Sdn. Bhd., located in Malaysia. The testing is retrospective, performed to demonstrate compliance with established standards for premarket notification.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a physical device, and the "ground truth" is established through standardized laboratory testing procedures based on material science and safety standards (ASTM, ISO), rather than expert interpretation of data like images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. As mentioned above, "adjudication" in the context of expert review of data is not relevant for this type of device testing. Performance is measured against objective, quantifiable criteria defined by the standards.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This is a physical device, not an AI/ML algorithm or a system involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This is a physical device, not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" is established by the specified ASTM and ISO standards themselves. These standards define the acceptable physical properties, chemical resistance, and biocompatibility limits for patient examination gloves. Laboratory tests are performed to objectively measure these characteristics against the defined thresholds.
8. The sample size for the training set:
- Not Applicable. This is a physical device; there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
- Not Applicable. There is no "training set" or AI/ML model for which ground truth would be established. Performance is based on direct physical and chemical testing.
{0}------------------------------------------------
APR 0 8 2014 K133949
TOP CALIBRE SDN. BHD.
FDA 510(k), Premarket Notification: 510(k) Summary
Date : April 01, 2014
1.0 Submitter:
Top Calibre Sdn. Bhd. Lot 13726, Jalan Haji Salleh, Batu 5 1/4, Off Jalan Meru, 41050 Klang, Selangor, Malaysia
| Telephone No.: | +603 3291 0516 |
|---|---|
| Fax No.: | +603 3291 0542 |
2.0 Contact Person:
| Contact: | Ms Rosnita Maodin |
|---|---|
| Telephone No.: | +603 3291 0516 |
| Fax No.: | +603 3291 0542 |
3.0 Name of Device:
| Trade Name(s) | : Powder Free Nitrile Patient Examination Glove,Blue Colored, Non-Sterile,Tested for Use with Chemotherapy Drugs.Powder Free Nitrile Patient Examination Glove,Orange Colored, Non-Sterile,Tested for Use with Chemotherapy Drugs. |
|---|---|
| Common Name | : Powder-Free Nitrile Patient Examination Glove |
| Classification Name | : Patient Examination Glove |
| Regulation Number | : 21 CFR 880.6250 |
| Classification Number | : Class I |
| Product Code | : 80 LZA, 80 LZC |
4.0 Identification of the Legally Marketed Device:
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Powder Free Nitrile Patient Examination Glove, Orange Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs, Class I Patient Examination Gloves, Nitrile - 80 LZA, Specialty - 80 LZC, meets all of the requirements of ASTM D 6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application.
Predicate Device: K091652, Nitrile Powder Free Examination Gloves (Blue) Tested for Use with Chemotherapy Drugs-VBLU
Page 1 of 9 (Rev 3)
{1}------------------------------------------------
There are no different technological characteristics compared to the Predicate Device.
5.0 Description of Device:
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Powder Free Nitrile Patient Examination Glove, Orange Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs meet all of the requirements of ASTM D6319-10.
The gloves are ambidextrous single-use disposable devices that come in five sizes (XS, S, M, L, XL) in blue or orange color.
Intended Use of the Device: 6.0
- Device Name: Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-6. I Sterile, Tested for Use with Chemotherapy Drugs
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
This glove has been tested for use with specific chemotherapy drugs listed below.
Chemotherapy Drug Permeation (Minimum Breakthrough Detection Time in Minutes)
| Carmustine (BCNU) (3.3 mg/ml) | 15.1 |
|---|---|
| Cisplatin (1.0 mg/ml) | >240 |
| Cyclophosphamide (Cytoxan) (20 mg/ml) | >240 |
| Cytarabine (100 mg/ml) | >240 |
| Dacarbazine (DTIC) (10.0 mg/ml) | >240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | >240 |
| Etoposide (20.0 mg/ml) | >240 |
| Fluorouracil (50.0 mg/ml) | >240 |
| Ifosfamide (50.0 mg/ml) | >240 |
| Methotrexate (25 mg/ml) | >240 |
| Mitomycin C (0.5 mg/ml) | >240 |
| Mitoxantrone (2.0 mg/ml) | >240 |
| Paclitaxel (Taxol) (6.0 mg/ml) | >240 |
| Thiotepa (10.0 mg/ml) | >240 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |
Please note that the following drug - Carmustine has extremely short permeation times of 15.1 minutes.
{2}------------------------------------------------
- Device Name: Powder Free Nitrile Patient Examination Glove, Orange Colored, Non-6.2 Sterile, Tested for Use with Chemotherapy Drugs
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
This glove has been tested for use with specific chemotherapy drugs listed below.
Chemotherapy Drug Permeation (Minimum Breakthrough Detection Time in Minutes)
| Carmustine (BCNU) (3.3 mg/ml) | 17.9 |
|---|---|
| Cisplatin (1.0 mg/ml) | >240 |
| Cyclophosphamide (Cytoxan) (20 mg/ml) | >240 |
| Cytarabine (100 mg/ml) | >240 |
| Dacarbazine (DTIC) (10.0 mg/ml) | >240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | >240 |
| Etoposide (20.0 mg/ml) | >240 |
| Fluorouracil (50.0 mg/ml) | >240 |
| Ifosfamide (50.0 mg/ml) | >240 |
| Methotrexate (25 mg/ml) | >240 |
| Mitomycin C (0.5 mg/ml) | >240 |
| Mitoxantrone (2.0 mg/ml) | >240 |
| Paclitaxel (Taxol) (6.0 mg/ml) | >240 |
| Thiotepa (10.0 mg/ml) | >240 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |
Please note that the following drug - Carmustine has extremely short permeation times of 17.9 minutes.
7.0 Summary of the Technological Characteristics of the Device:
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Powder Free Nitrile Patient Examination Glove, Orange Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs posses the following technological characteristic (as compared to ASTM or equivalent standards):
{3}------------------------------------------------
| Characteristic | StandardsRequirements | Results Summary | Conclusions | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Dimensions | ASTM D6319-10 | Length ≥ 270mmPalm Thickness ≥ 0.10mmFinger Thickness ≥ 0.10mmWidthX-Small 70-80mmSmall 80-90mmMedium 90-100mmLarge 101-111mmX-Large ≥ 111mm | MeetsStandardRequirements | |||||||||
| PhysicalProperties | ASTM D6319-10 | Before Aging After Aging Tensile Strength ≥ 14 MPA ≥ 14 MPA Elongation > 500% > 400% | MeetsStandardRequirements | |||||||||
| Freedom frompinholes | ASTM D5151-11ASTM D6319-10 | Tested in accordance with ASTM D5151 testmethod. Pass quality level at G1 AQL 1.5 | MeetsStandardRequirements | |||||||||
| Powder FreeResidue | ASTM D6124-11ASTM D6319-10 | Result generated values ≤ 2 mg of residual powderper glove | MeetsStandardRequirements | |||||||||
| Biocompatibility | Dermal Sensitization(as ISO 10993-10:2010) | Not a contact skin sensitizer | MeetsStandardRequirements | |||||||||
| Primary Skin IrritationTest (as ISO 10993-10:2010) | Not a primary skin irritant | |||||||||||
| ChemotherapyDrugsPermeation TestMethod | ASTM D6978-05 | Powder Free Nitrile Patient Examination Glove,Blue Colored, Non-Sterile, Tested for Use withChemotherapy DrugsChemotherapy Drug Permeation(Minimum Breakthrough Detection Time in Minutes) | Tested for UsewithChemotherapyDrugs.Carmustinehas extremelyshortpermeationtimes of 15.1minutes. | |||||||||
| Carmustine (3.3 mg/ml) 15.1Cisplatin (1.0 mg/ml) >240Cyclophosphamide (20 mg/ml) >240Cytarabine (100 mg/ml) >240Dacarbazine (DTIC) (10.0 mg/ml) >240Doxorubicin Hydrochloride (2.0 mg/ml) >240Etoposide (20.0 mg/ml) >240Fluorouracil (50.0 mg/ml) >240Ifosfamide (50.0 mg/ml) >240Methotrexate (25 mg/ml) >240Mitomycin C (0.5 mg/ml) >240Mitoxantrone (2.0 mg/ml) >240Paclitaxel (Taxol) (6.0 mg/ml) >240Thiotepa (10.0 mg/ml) >240Vincristine Sulfate (1.0 mg/ml) >240 |
{4}------------------------------------------------
| Characteristic | StandardsRequirements | Results Summary | Conclusions |
|---|---|---|---|
| ChemotherapyDrugsPermeation TestMethod | ASTM D6978-05 | Powder Free Nitrile Patient Examination Glove,Orange Colored, Non-Sterile, Tested for Use withChemotherapy Drugs | |
| Chemotherapy Drug Permeation(Minimum Breakthrough Detection Time in Minutes) | Tested for Usewith | ||
| Carmustine (3.3 mg/ml) | 17.9 | ||
| Cisplatin (1.0 mg/ml) | >240 | ||
| Cyclophosphamide (20 mg/ml) | >240 | ||
| Cytarabine (100 mg/ml) | >240 | ||
| Dacarbazine (DTIC) (10.0 mg/ml) | >240 | ||
| Doxorubicin Hydrochloride (2.0 mg/ml) | >240 | ||
| Etoposide (20.0 mg/ml) | >240 | ||
| Fluorouracil (50.0 mg/ml) | >240 | ||
| Ifosfamide (50.0 mg/ml) | >240 | ||
| Methotrexate (25 mg/ml) | >240 | ||
| Mitomycin C (0.5 mg/ml) | >240 | ||
| Mitoxantrone (2.0 mg/ml) | >240 | ||
| Paclitaxel (Taxol) (6.0 mg/ml) | >240 | ||
| Thiotepa (10.0 mg/ml) | >240 | ||
| Vincristine Sulfate (1.0 mg/ml) | >240 | ||
| ChemotherapyDrugs.Carmustinehas extremelyshortpermeationtimes of 17.9minutes. |
8.0 Substantial Equivalent Based on Assessment of Non-Clinical Performance Data
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Powder Free Nitrile Patient Examination Glove, Orange Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs have been tested against the applicable ASTM standards listed above, and meet the requirements set forth in those standards.
There is no difference between the Proposed Devices and the Predicate Device with respect to performance standard and technological characteristics.
There is difference in colorant used in one of the Proposed Device (Orange), compared with Predicate Device (Blue). However, the difference does not affect the safety and effectiveness of the Proposed Device (Orange), as the Proposed Device (Orange) tested and passed Biocompatibility test, similar with Predicate Device.
The Proposed Devices were tested for 15 drugs, while the Predicate Device was tested for 12 drugs. The respective drug's permeation result is shown in Indication for Use of the Proposed Devices. The difference in labeling (with additional drugs tested, exceed ASTM D6978-05 requirements), and in Indications for Use do not affect the safety and effectiveness of the proposed devices.
{5}------------------------------------------------
9.0 Substantial Equivalent Based on Assessment of Clinical Performance Data
Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.
10.0 Conclusion
It can be concluded that the Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Powder Free Nitrile Patient Examination Glove, Orange Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs are substantially equivalent to the predicate device identified in this 510(k) summary.
The Substantial Equivalent Comparison Table below outlines the similarity, and/or differences between the proposed devices and the predicate device for the substantial equivalent determination.
As such, this device is substantially equivalent to predicate device.
{6}------------------------------------------------
| BHD. |
|---|
| SDN. |
| CALIBRE |
| TOP |
Substantial Equivalent Comparison Table
.
| ics | Predicate Device | Proposed Device (Blue) | Predicate Device | Proposed Device (Orange) | |
|---|---|---|---|---|---|
| K091652 Nitrile Powder FreeExamination Gloves (Blue) Testedfor Use with ChemotherapyDrugs-VBLU | Powder Free Nitrile PatientExamination Glove, BlueColored, Non-Sterile, Tested forUse with Chemotherapy Drugs | K091652 Nitrile Powder FreeExamination Gloves (Blue) Testedfor Use with ChemotherapyDrugs-VBLU | Powder Free Nitrile PatientExamination Glove, OrangeColored, Non-Sterile, Tested forUse with Chemotherapy Drugs | ||
| cription/umber | Patient Examination Glove/21 CFR Part 880.6250 | Substantial Equivalent | Patient Examination Glove/21 CFR Part 880.6250 | Substantial Equivalent | |
| 80 LZA, 80 LZC | 80 LZA, 80 LZC | 80 LZA, 80 LZC | 80 LZA, 80 LZC | ||
| Intended for medical and dentalpurposes that is worn on theexaminer's hand to preventcontamination between patient andexaminer. | Substantial Equivalent | Intended for medical and dentalpurposes that is worn on theexaminer's hand to preventcontamination between patient andexaminer. | Substantial Equivalent | ||
| Characteristics | Predicate DeviceK091652 Nitrile Powder FreeExamination Gloves (Blue) Tested forUse with Chemotherapy Drugs-VBLU | Proposed Device (Blue)Powder Free Nitrile PatientExamination Glove, Blue Colored,Non-Sterile, Tested for Use withChemotherapy Drugs | Predicate DeviceK091652 Nitrile Powder FreeExamination Gloves (Blue) Tested forUse with Chemotherapy Drugs-VBLU | Proposed Device (Orange)Powder Free Nitrile PatientExamination Glove, Orange Colored,Non-Sterile, Tested for Use withChemotherapy Drugs | |
| Indications for Use | The Nitrile Examination Glove (Testedfor Use with Chemotherapy Drugs) is adisposable device intended for medicaland dental-purposes that is worn on theexaminer's hand to preventcontamination between patient andexaminer. The list of chemotherapydrugs tested (with breakthrough times)are as follows:- | A patient examination glove is adisposable device intended formedical purposes that is worn on theexaminer's hand to preventcontamination between patient andexaminer.This glove has been tested for usewith specific chemotherapy drugslisted below. | The Nitrile Examination Glove(Tested for Use with ChemotherapyDrugs) is a disposable device intendedfor medical and dental purposes that isworn on the examiner's hand toprevent contamination between patientand examiner. The list ofchemotherapy drugs tested (withbreakthrough times) are as follows:- | A patient examination glove is adisposable device intended formedical purposes that is worn on theexaminer's hand to preventcontamination between patient andexaminer.This glove has been tested for usewith specific chemotherapy drugslisted below. | |
| Chemotherapy Drug Permeation(Minimum Breakthrough DetectionTime in Minutes) | Chemotherapy DrugsBreakthrough Time (Minutes) | Chemotherapy Drug Permeation(Minimum Breakthrough DetectionTime in Minutes) | |||
| Carmustine (3.3 mg/ml) | Carmustine | 6.60 | |||
| Cisplatin (1.0 mg/ml) | Cisplatin | >240 | |||
| Cyclophosphamide(20mg/ml) | Cyclophosphamide (Cytoxan) | >240 | |||
| Cytarabine (100 mg/ml) | Dacarbazine | >240 | |||
| Dacarbazine (DTIC)(10.0 mg/ml) | Doxorubicin Hydrochloride | >240 | |||
| Doxorubicin Hydrochloride(2.0 mg/ml) | Etoposide | >240 | |||
| Etoposide (20.0 mg/ml) | Fluorouracil | >240 | |||
| Fluorouracil (50.0 mg/ml) | Methotrexate | >240 | |||
| Ifosfamide (50.0 mg/ml) | Mitomycin C | >240 | |||
| Methotrexate (25 mg/ml) | Paclitaxel | >240 | |||
| Mitomycin C (0.5 mg/ml) | Thiotepa | 14.83 | |||
| Mitoxantrone (2.0 mg/ml) | Vincristine Sulfate | >240 | |||
| Paclitaxel (Taxol) (6.0 mg/ml) | Warning: Do not use withCarmustine and Thiotepa. | ||||
| Thiotepa (10.0 mg/ml) | |||||
| Vincristine Sulfate (1.0 mg/ml) | |||||
| Please note that the following drug- Carmustine has extremely shortpermeation times of 17.9 minutes. |
Page 7 of 9 (Rev 3)
. . . .
.
{7}------------------------------------------------
Page 8 of 9 (Rev 3)
:
{8}------------------------------------------------
| BHD. |
|---|
| SDN. |
| CALIBRE |
| ГОР |
| Characteristics | Predicate DeviceK091652 Nitrile Powder FreeExamination Gloves (Blue) Testedfor Use with ChemotherapyDrugs-VBLU | Proposed Device (Blue)Powder Free Nitrile PatientExamination Glove, BlueColored, Non-Sterile, Tested forUse with Chemotherapy DrugsSubstantial Equivalent | Predicate DeviceK091652 Nitrile Powder FreeExamination Gloves (Blue) Testedfor Use with ChemotherapyDrugs-VBLU | Proposed Device (Orange)Powder Free Nitrile PatientExamination Glove, OrangeColored, Non-Sterile, Tested forUse with Chemotherapy DrugsSubstantial Equivalent |
|---|---|---|---|---|
| Materials | Nitrile | Substantial Equivalent | Nitrile | Substantial Equivalent |
| Color | Blue | Substantial Equivalent | Blue | Orange |
| Design | Ambidextrous, in different sizesper ASTM D6319 dimensionrequirement. | Substantial Equivalent | Ambidextrous, in different sizesper ASTM D6319 dimensionrequirement. | Substantial Equivalent |
| PerformanceI. Sterility | Not Applicable (Non-Sterile) | Substantial Equivalent | Not Applicable (Non-Sterile) | Substantial Equivalent |
| II. Freedom fromholes | Passes at AQL 1.5 | Passes at AQL 1.5 (SubstantialEquivalent) | Passes at AQL 1.5 | Passes at AQL 1.5 (SubstantialEquivalent) |
| III. Dimension | Meets ASTM D6319 | Meets ASTM D6319 (SubstantialEquivalent) | Meets ASTM D6319 | Meets ASTM D6319 (SubstantialEquivalent) |
| IV. PhysicalProperties | Meets ASTM D6319 | Meets ASTM D6319 (SubstantialEquivalent) | Meets ASTM D6319 | Meets ASTM D6319 (SubstantialEquivalent) |
| V. Powder FreeResidue | Meets ≤ 2 mg/glove | Meets ≤ 2 mg/glove (SubstantialEquivalent) | Meets ≤ 2 mg/glove | Meets ≤ 2 mg/glove (SubstantialEquivalent) |
| Single Use | Yes | Substantial Equivalent | Yes | Substantial Equivalent |
| BiocompatibilityTest | Passesi. Primary Skin Irritation Testii. Dermal Sensitization Test | Not an irritantNot a contact sensitizer | Passesi. Primary Skin Irritation Testii. Dermal Sensitization Test | Not an irritantNot a contact sensitizer |
| Packaging | Packed in Dispenser Boxes | Substantial Equivalent | Packed in Dispenser Boxes | Substantial Equivalent |
| Labeling Claim | Tested For Use withChemotherapy Drugs | Substantial Equivalent | Tested For Use withChemotherapy Drugs | Substantial Equivalent |
Page 9 of 9 (Rev 3)
{9}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/9/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002
April 8, 2014
Top Calibre Sdn. Bhd. Ms. Rosnita Maodin Quality Assurance Manager Lot 13726, Jalan Haji Salleh, Batu 5 ¼ , Off Jalan Meru Klang, Selangor MALAYSIA 41050
Re: K133949
Trade/Device Name: Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Tested for Use with Chemotherapy Drugs and Powder Free Nitrile Patient Examination Glove, Orange Colored, Non-sterile, Tested for Use with Chemotherapy Drugs
Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA, LZC Dated: March 3, 2014 Received: March 6, 2014
Dear Ms. Maodin:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
{10}------------------------------------------------
Page 2 - Ms. Maodin
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 t CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
Sincerely yours,
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Tejashri Purohit-Sheth, M.D.
Clinical Deputy Director
DAGRID
FOR
Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{11}------------------------------------------------
Indications for Use
510(k) Number (if known):
Device Name:
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs
Indications for Use:
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This glove has been tested for use with specific chemotherapy drugs listed below.
Chemotherapy Drug Permeation (Minimum Breaktbrough Detection Time in Minutes)
| Carmustine (BCNU) (3.3 mg/ml) | 15.1 |
|---|---|
| Cisplatin (1.0 mg/ml) | > 240 |
| Cyclophosphamide (Cytoxan) (20 mg/ml) | > 240 |
| Cytarabine (100 mg/ml) | > 240 |
| Dacarbazine (DTIC) (10.0 mg/ml) | > 240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | > 240 |
| Etoposide (20.0 mg/ml) | > 240 |
| Fluorouracil (50.0 mg/ml) | > 240 |
| Ifosfamide (50.0 mg/ml) | > 240 |
| Methotrexate (25 mg/ml) | > 240 |
| Mitomycin C (0.5 mg/ml) | > 240 |
| Mitoxantrone (2.0 mg/ml) | > 240 |
| Paclitaxel (Taxol) (6.0 mg/ml) | > 240 |
| Thiotepa (10.0 mg/ml) | > 240 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |
Please note that the following drug - Carmustine has extremely short permeation times of 15.1 minutes.
AND/OR Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (2) CFR 801 Subpan C) x
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office Of Device Evaluation (ODE)
Elizabeth F. Claverie -S 2014.04.07 23:45:16 -04'00'
Page 1 of _
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Indications for Use
510(k) Number (if known):
Device Name:
Powder Free Nitrile Patient Examination Glove, Orange Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs
Indications for Use:
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This glove has been tested for use with specific chemotherapy drugs listed below.
Chemotherapy Drug Permeation (Minimum Breakthrough Detection Time in Minutes)
| Carmustine (BCNU) (3.3 mg/ml) | 17.9 |
|---|---|
| Cisplatin (1.0 mg/ml) | > 240 |
| Cyclophosphamide (Cytoxan) (20 mg/ml) | > 240 |
| Cytarabine (100 mg/ml) | > 240 |
| Dacarbazine (DTIC) (10.0 mg/ml) | > 240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | > 240 |
| Etoposide (20.0 mg/ml) | > 240 |
| Fluorouracil (50.0 mg/ml) | > 240 |
| Ifosfamide (50.0 mg/ml) | > 240 |
| Methotrexate (25 mg/ml) | > 240 |
| Mitomycin C (0.5 mg/ml) | > 240 |
| Mitoxantrone (2.0 mg/ml) | > 240 |
| Paclitaxel (Taxol) (6.0 mg/ml) | > 240 |
| Thiotepa (10.0 mg/ml) | > 240 |
| Vincristine Sulfate (1.0 mg/ml) | > 240 |
Please note that the following drug . Carmustine has extremely short permeation times of 17,9 minutes.
× AND/OR Prescription Use Over-The-Counter Use (Part 2) CFR 801 Subpart D) (2) 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)
Elizabeth F. Claverie -S 2014.04.07 23:46:05 -04'00'
Page I of .
§ 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.