Independent Laboratory Testing (Nitrile N801 Series)
If you have any questions please contact Brian Haggie, HighFive Products, Inc. 1-800-253-9292
| Proper or Item of Information | Test Name, Methodology, & Cost*2 | No. Gloves / lot per year | No. Lots / year | Glove Sources- Internal production or random distributor purchase | Results | Specify results type / unit (e.g. mcg/mg) | Variability - data from lot to lot over time & Between assays | Performed by (name of individual) |
| (absolute and normalized) | ||||||||
| Glove Barrier Efficacy | ||||||||
| Chemical Penetration: Gluteraldehyde | Permeation / Random - Sampling / $200 | 1 | 1 | Internal Production | No penetration in the last 8 hours | Time (seconds, minutes, hours) | No difference | M. Grossman |
| Chemical Penetration: Methyl Methacrylate | Permeation / Random - Sampling / $200 | 1 | 1 | Internal Production | No penetration in the last 8 hours | Time (seconds, minutes, hours) | No difference | M. Grossman |
| Viral Penetration (ASTM F 1671): bacteriophage X17** | ASTM - F1671 / Random - Sampling / $550 | 1 | 1 | Internal Production | Compliant | PFU / ML | 0 | C. Dodgen |
| Powder Particulate Levels (ASTM D 6124) | ||||||||
| Surface extractable-state by average glove size in mg | ASTM - D6124 / Random - Sampling/ $200 | 13 | 4 | Internal Production | 1.32 mg/glove | mg/glove | <0.50 mg/glove | M. Grossman |
| Assay accurate to 0.1 mg levels or state what level (powder free </=2 mg/glove) | N/A | N/A | N/A | N/A | ||||
| Protein Level Testing | ||||||||
| Modified Lowry (ASTM D 5712) - Results in mcg/Gm of glove): detection limit of 0.2 mcg/Gm | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A |
| Leap (Guthrie Method): detection limit of 0.2 mcg/Gm | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A |
| Mayo Reference Laboratory | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A |
| Latex Antigen Level Testing | ||||||||
| Soluble levels of release RAST (IBT Reference Lab)*1 | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A |
| Endotoxin | ||||||||
| LAL: Kinetic Turbidmetric (USP XXIII FDA LAL guideline) in EU/glove | In Process - LAL / Random - Sampling / $600 | 3 | 1 | Internal Production | negative | EU/glove | 0 | S. Carls |
| Chemical Accelerator Residues | ||||||||
| Mercaptobenzothiazole (MBP): detection limit 60 mcg/Gm | HPLC / Random - Sampling / $200 | 1 | 1 | Internal Production | Non-detectable | mcg/gm | 0 | M. Grossman |
| Carbamates | ||||||||
| Diisobutyldithiocarbamate (DiBC): detection limit 132 mcg/Gm | HPLC / Random - Sampling / $50 | 1 | 1 | Internal Production | Non-detectable | mcg/gm | 0 | Y. Xu |
| Diisobutyldithiocarbamate (DiBC): detection limit 120 mcg/Gm | HPLC / Random - Sampling / $50 | 1 | 1 | Internal Production | Non-detectable | mcg/gm | 0 | Y. Xu |
| Diisobutyldithiocarbamate (DiBC): detection limit 192 mcg/Gm | HPLC / Random - Sampling / $400 | 3 | 4 | Internal Production | Below detection limits | mcg/gm | <60 mcg/gm | M. Grossman |
| DTC In <0.25% ww or <0.1% | HPLC / Random - Sampling / $50 | 1 | 1 | Internal Production | Non-detectable | mcg/gm | 0 | Y. Xu |
| DTC In <0.05% ww | HPLC / Random - Sampling / $50 | 1 | 1 | Internal Production | Non-detectable | Non-detectable | 0 | Y. Xu |
| Thiurams | ||||||||
| Rsidue Levels | HPLC / Random - Sampling / $50 | 1 | 1 | Internal Production | Non-detectable | Non-detectable | 0 | Y. Xu |
| Present (P) or Absent (A) | Absent | N/A | N/A | N/A | N/A | N/A | N/A | N/A |
| If used in manufacturing give levels | Do not use thiurams | N/A | N/A | N/A | N/A | N/A | N/A | N/A |
| * 1 - Attach reference data, defined units, ranking units, detection limits | ||||||||
| * 2 - Estimated cost per test "inhouse" and/or outsourced | ||||||||
| If you have any questions please contact Brian Haggie (800) 545-8823 |