Nasal Strip & Mouth Tape Skin Safety: The Complete Guide
Strips that touch your skin every night should be proven safe — not just claimed safe. Here is exactly how HLK tests nasal strips and mouth tapes for skin contact, what is (and isn’t) in the adhesive, and how to use them without irritation.
Why Skin Safety Actually Matters
Nasal strips and mouth tapes sit directly on facial skin — across the nose bridge and around the lips — for hours at a time, often overnight. The adhesive, not the fabric, is what your skin reacts to. A poorly formulated adhesive can cause redness, itching or contact dermatitis, especially on sensitive or repeatedly-used skin. For brands and importers, “skin safe” is therefore a materials-and-testing question, not a marketing line.
What’s Actually in an HLK Strip
Medical-grade backing
A flexible non-woven or woven carrier chosen for breathability and comfort on skin. A typical nasal strip build is 50–60% non-woven, 25–35% coated paper, 15–25% medical acrylic adhesive, plus a PET stiffening strip — chemically stable, with no hazardous components declared in the material MSDS on file.
Acrylic adhesive system
A medical-grade acrylic (Henkel LOCTITE DURO-TAK 129A) provides overnight hold. The adhesive film itself was independently tested by SGS to ISO 10993-10:2010 with a primary irritation score of 0 (non-irritant). Full MSDS/SDS per material are on file and available on request.
No unnecessary additives
Formulated PFAS-free — 675 PFAS compounds screened, none detected — and low-VOC, with REACH and RoHS compliance documented. We avoid fragrance and latex where skin contact is concerned.
How We Test for Skin Safety
Skin safety is evaluated, not assumed. HLK strips are assessed for biocompatibility under the ISO 10993 family of standards used for medical devices in contact with skin. The adhesive — a medical-grade acrylic (LOCTITE DURO-TAK 129A) — was independently tested by SGS to ISO 10993-10:2010 using a rabbit primary skin-irritation model, returning a primary irritation score of 0 (non-irritant). These are safety tests — they confirm the product is suitable for skin contact. They are not clinical efficacy trials, and HLK makes no clinical efficacy claims about breathing or sleep improvement.
Skin Irritation
ISO 10993-10
Evaluated for skin-irritation potential on contact, the most common concern with overnight adhesive wear.
Sensitization
ISO 10993-10
Assessed for delayed skin-sensitization risk — relevant for users who wear strips repeatedly over weeks.
Cytotoxicity
ISO 10993-5
In-vitro cytotoxicity screening confirms the materials do not release skin-harmful substances under use conditions.
HLK’s biocompatibility and chemical-safety test reports — including third-party results from SGS, CTI and KTi — are available on request to verified B2B buyers. This guide summarises the testing scope; it is not a substitute for the full certificate set provided with an order.
| Documented result | Test / Standard | Outcome |
|---|---|---|
| Skin irritation (adhesive film) | ISO 10993-10:2010 — SGS, rabbit primary skin-irritation model | Score 0 — non-irritant |
| SVHC screening (nasal strips) | EU REACH — ECHA Candidate List (250 substances) | All ≤ 0.1% (w/w) — PASS |
| Restricted substances | RoHS 2.0 (EU 2015/863) — Pb, Cd, Hg, Cr(VI), PBBs, PBDEs, phthalates | Not detected or within limits |
| PFAS (mouth tape) | EN 17681-1:2025 — 675 PFAS compounds, LC-MS-MS / GC-MS-MS | None detected |
| Free formaldehyde | HPLC — adhesive emission testing | Not detected (< 0.01 g/kg detection limit) |
| VOC content | Adhesive VOC content method (GB 33372-2020) | 28 g/kg — low-VOC adhesive |
Selected results excerpted from laboratory reports (SGS; Centre Testing International / CTI; KTi) on file at HLK. Report numbers are withheld from public pages; full PDFs are shared with verified B2B buyers.
Chemical Safety: What’s Not In Them
PFAS-free
Per- and polyfluoroalkyl substances (“forever chemicals”) are excluded. A third-party scan of the adhesive patch covered 675 PFAS compounds (EN 17681-1:2025) — none detected.
Low VOC & no formaldehyde
Volatile organic compound emissions are controlled and tested: free formaldehyde not detected (< 0.01 g/kg), adhesive VOC content measured at 28 g/kg — reducing odour and inhalation exposure during use.
REACH & RoHS
EU REACH: all 250 substances on the ECHA SVHC Candidate List screened at ≤ 0.1% (w/w) — PASS. RoHS 2.0 (EU 2015/863): cadmium, lead, mercury, hexavalent chromium, phthalates and brominated flame retardants not detected or within limits across nasal strips, mouth tapes and face tapes.
Regulatory Compliance
HLK (Quanzhou Honglinkai New Material Co., Ltd.) is the manufacturing factory behind the strips, and holds the documentation B2B buyers expect:
- CE — EU MDR 2017/745 (Class I): declaration of conformity, technical file and UDI; an EU Authorized Representative (Spain) is appointed for the European route. The technical file references EN ISO 13485:2016, EN ISO 14971:2019 (risk management) and the ISO 10993 biocompatibility series (ISO 10993-5, -10, -23).
- UKCA: UK Conformity Assessed marking for the Great Britain market.
- FDA establishment registration: facility registration and device listing for the US route.
- ISO 13485: ISO 13485:2016 quality-management certification (GB/T 42061-2022) covering the medical-adhesive processing chain.
- RoHS 2.0 (EU 2015/863, as amended by (EU) 2017/2102): restricted substances tested across nasal strips, mouth tapes and face tapes.
Certificate numbers are withheld from public pages to prevent misuse; full PDFs are provided to verified buyers with samples or orders.
How to Use Strips Safely
- Patch-test first. Apply a strip to the inner forearm for 24 hours before first facial use, especially if you have sensitive skin.
- Avoid broken skin. Do not apply over cuts, active acne, eczema, sunburn or irritated areas.
- Know your allergies. If you have a known allergy to acrylic adhesives or latex, check with a professional before use.
- Remove gently. Peel off slowly; use warm water or oil if resistance is high, rather than yanking.
- Stop on reaction. Redness, itching or swelling means remove immediately and discontinue use.
- Supervise children. Not intended for unsupervised use by young children; consult a physician where relevant.
Certificates on File
HLK holds the certificates and test reports below. For anti-fraud reasons, numbers are not published on this page — full PDFs with numbers are shared with verified B2B buyers on request.
ISO 10993 biocompatibility, UKCA, FDA registration and ISO 13485 documents are also on file. Request the full set with your sample order.
Want the Full Certificate Set?
We’ll send our ISO 10993 biocompatibility reports, CE MDR, UKCA, FDA, ISO 13485, REACH and batch MSDS/COA with your sample order.
Skin Safety FAQ
Are nasal strips and mouth tapes safe for skin?
What does "ISO 10993 biocompatibility" mean?
Are HLK adhesives PFAS-free?
Can people with sensitive skin use them?
What should I do if I get redness or itching?
Do these strips treat or cure snoring?
More questions? Visit our full FAQ page or contact our team.